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GLYPHOSATE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs: Special Review and Reregistration Division Eric Feris . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reregistration Branch Health Effects Division Jane Smith . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chemical Coordination Branch Krystyna Locke . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Toxicology Branch I Jeff Evans . . . . . . . . . . . . . . . . . . . . . . . . . . . cc!pational and Residential Expos!re Branch Randolph Perfetti . . . . . . . . . . . . . . . . . . . . . . . . . Chemistry Branch " Reregistration S!pport Biological and Economic #nalysis Division James G. Saulmon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Biological #nalysis Branch Eric Maurer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Economic #nalysis Branch Environmental $ate and Effects Division andace !rassard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ecological Effects Branch Kevin Poff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environmental $ate and %ro!ndwater Branch !ernice Slutsky . . . . . . . . . . . . . . . . . . . . . . . . . . . . Science #nalysis and Coordination Staff Registration Division Mark Perry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Registration S!pport Branch Karen P. "icks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $!ngicide"Her&icide Branch 'olicy and Special 'ro(ects Staff Jean Frane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ood Safety ) Reg!lation Trac*ing Section Office of General o!nsel:
'esticides and Toxic S!&stances Division #e$ra !urton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 'esticides Branch
Office of
om"liance Monitoring:
'olicy and %rants Division !everly %pdike . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $I$R# 'olicy ) #nalysis Branch i
GLYPHOSATE RED September 1993
TABLE O#
ONTENTS
GLOSSARY O# TERMS AN$ ABBRE%IATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . vi E&E 'TI%E S'MMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii I( II( INTRO$' TION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . + ASE O%ER%IE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,
A( B( ( $( E( *emical O+er+ie, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 'se Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Estimated 'sage of Pesticide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ata Re-!irements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reg!lator. Histor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , , . .
III(
S IEN E ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A( B( Prod!ct *emistr. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
H!man Healt* Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +/ +. Toxicology #ssessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +/ a. &. c. d. e. #c!te Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +/ S!&chronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ++ Chronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +, Carcinogenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +0 Developmental Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +1
ii
f. g. h. i. (. *. ,.
Reprod!ctive Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +2 3!tagenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +3eta&olism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +4e!rotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +5 ther Toxicological Endpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . +. Reference Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +.
Expos!re #ssessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,/ a. &. Dietary Expos!re . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,/ cc!pational and Residential . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,+
0.
Ris* #ssessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,0 a. &. c. Dietary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,0 cc!pational and Residential . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,6 Dietary Expos!re References . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,6
En+ironmental Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0/ +. Environmental $ate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0/ a. &. 0,. Ecological Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0a. &. Ecological Ha7ard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0Ecological Effects Ris* #ssessment . . . . . . . . . . . . . . . . . . . . . . 10 Environmental $ate and Transport . . . . . . . . . . . . . . . . . . . . . . . . 0/ Environmental $ate and %ro!ndwater #ssessment . . . . . . . . . .
I%(
RIS/ MANAGEMENT AN$ REREGISTRATION $E ISION . . . . . . . . 1-
A(
$etermination of Eligi0ilit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1+. ,. Eligi&ility Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Eligi&le and Ineligi&le 8ses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
B(
Reg!lator. Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 +. ,. 0. Tolerance Re"assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 9a&eling Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -/ Endangered Species Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -/
%(
A TIONS RE1'IRE$ BY REGISTRANTS . . . . . . . . . . . . . . . . . . . . . . . . . . -/

A( Man!fact!ring2'se Prod!cts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -/ +. ,. B( #dditional %eneric Data Re:!irements . . . . . . . . . . . . . . . . . . . . . . . . . . -/ 9a&eling Re:!irements for 3an!fact!ring"8se 'rod!cts . . . . . . . . . . . -+
End2'se Prod!cts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -+ +. ,. #dditional 'rod!ct"Specific Data Re:!irements . . . . . . . . . . . . . . . . . . -+ 9a&eling Re:!irements for End"8se 'rod!cts . . . . . . . . . . . . . . . . . . . . -, a. 4ona:!atic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -, &. #:!atic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -,
E3isting Stoc4s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -6
%I(
APPEN$I ES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -6
8se 'atterns S!&(ect to Reregistration Ta&le of the %eneric Data Re:!irements and St!dies 8sed to 3a*e the Reregistration Decision
A""endi3 A " A""endi3 B "
A""endi3 "
"
Citations Considered to &e 'art of the Data Base S!pporting the Reregistration of %lyphosate A""endi3 $
9ist of #vaila&le Related Doc!ments A""endi3 E "
'esticide Reregistration Hand&oo* A""endi3 # " %eneric and 'rod!ct"Specific Data Call"In ; #ttachment + " ; #ttachment , " Response ; #ttachment 0 " ; #ttachment 6 " Toxicology ; #ttachment 1 " ; #ttachment 2 " ; #ttachment - " Chemical Stat!s Sheet %eneric Data Call"In and 'rod!ct Specific Data Call"In $orms with Instr!ctions %eneric Data Call"In and 'rod!ct Specific Data Call"In Re:!irements Stat!s and Registrants< Response $orms with Instr!ctions E'# %ro!ping of End 8se 'rod!cts for 3eeting #c!te Data Re:!irements. E'# #cceptance Criteria 9ist of all Registrant=s> sent this Data Call"In Cost Share?Data Compensation $orms
GLOSSARY O# TERMS AN$ ABBRE%IATIONS

a.i. C#S C$R CS$ EEC E' E'# $I$R# $$DC# $R HDT 9C1/ #ctive Ingredient Chemical #&stracts Service Code of $ederal Reg!lations Confidential Statement of $orm!la Estimated Environmental Concentration. The estimated pesticide concentration in an environment@ s!ch as a terrestrial ecosystem. End"8se 'rod!ct 8.S. Environmental 'rotection #gency $ederal Insecticide@ $!ngicide@ and Rodenticide #ct $ederal $ood@ Dr!g@ and Cosmetic #ct $ederal Register Highest Dose Tested 3edian 9ethal Concentration. # statistically derived concentration of a s!&stance that can &e expected to ca!se death in 1/A of test animals. It is !s!ally expressed as the weight of s!&stance per weight or vol!me of water or feed@ e.g.@ mg?l or ppm. 3edian 9ethal Dose. # statistically derived single dose that can &e expected to ca!se death in 1/A of the test animals when administered &y the ro!te indicated =oral or dermal>. It is expressed as a weight of s!&stance per !nit weight of animal@ e.g.@ mg?*g. 9ethal Dose"low. 9owest Dose at which lethality occ!rs 9owest Effect 9evel
9D1/
9Dlo 9E9
3#TC
3axim!m #llowa&le Toxicant ConcentrationB # range at which the pesticide ca!ses no effect =4 E9> and the lowest dose at which an effect was o&served =9 E9>. 3an!fact!ring"8se 'rod!ct 3axim!m 'ermissi&le Inta*e 3aster Record Identification =n!m&er>. E'#<s system of recording and trac*ing st!dies s!&mitted. 4ot #pplica&le 4ational 'oll!tant Discharge Elimination System 4o &served Effect 9evel
3' 3'I 3RID 4?# 4'DES 4 E9 '' '#DI ppm REI RfD RS TD TC effect. T3RC C'S
ffice of 'esticide 'rograms 'rovisional #ccepta&le Daily Inta*e 'arts 'er 3illion Restricted Entry Interval Reference Dose Registration Standard Toxic Dose. The dose at which a s!&stance prod!ces a toxic effect. Toxic Concentration. The dose at which a s!&stance prod!ces a toxic Theoretical 3axim!m Resid!e Contri&!tion. Cor*er 'rotection Standard
vii
E&E 'TI%E S'MMARY

This doc!ment addresses the reregistration eligi&ility of the pesticide glyphosate. There are 20 glyphosate"containing prod!cts registered for !se in the 8nited States. The isopropylamine salt of glyphosate@ the active ingredient in 10 of these registrations@ is !sed as a her&icide to control a n!m&er of &roadleaf weeds and grasses. The principal food !se sites incl!de corn@ wheat@ sorgh!m@ citr!s and stone fr!its@ potatoes and onions@ asparag!s@ coffee@ pean!ts@ and pineapples. There are also a n!m&er of non"food !se sites incl!ding ornamental@ t!rf@ forestry@ and ind!strial rights"of"way. Two registrations contain the sodi!m salt of glyphosate and are !sed in s!garcane fields. In addition there are seven her&icide?plant reg!lation prod!cts containing the monoammoni!m salt of glyphosate which were registered s!&se:!ent to the development of 9ist # and are not a s!&(ect of this RED. Except where explicitly noted otherwise@ the term Dglyphosate@D when !sed in this doc!ment@ refers to either the technical acid or the isoproplyamine and sodi!m salts of glyphosate. However@ the monoammoni!m salt is incl!ded in the tolerance expression. #vaila&le data have &een s!fficient to allow re"assessment of existing tolerances@ which incl!des the monoammoni!m salt of glyphosate. In E!ne +.52@ the #gency iss!ed the doc!ment DRegistration Standard for 'esticide 'rod!cts Containing %lyphosate as the #ctive IngredientD =4TIS F'B5-"+/0,+6>. The Registration Standard re:!ired scientific st!dies in the areas of phytotoxicity@ environmental fate@ toxicology@ prod!ct chemistry@ and resid!e chemistry. Cith the exception of a few waived st!dies@ all of the data re:!ired have &een s!&mitted. #fter completing its review for reregistration@ the #gency now concl!des that the data &ase on glyphosate is s!&stantially complete. Based on the res!lts of its reregistration review@ E'# has concl!ded that all registered !ses of glyphosate are eligi&le for reregistration. The #gency has classified glyphosate as a %ro!p E carcinogen =signifies evidence of non"carcinogenicity in h!mans>. # Reference Dose of , mg?*g?day has &een recommended. This proposal is &ased on a maternal 4 E9 of +-1 mg?*g?day from a ra&&it developmental toxicity st!dy and an !ncertainty factor of +//. The dietary ris* assessment is &ased on a worst"case scenario@ ass!ming treatment of +//A of acreage and highest legal resid!e val!es which li*ely res!lt in an overestimation of expos!re and ris*. Even with these val!es@ however@ dietary expos!re is expected to &e minimal. There are 51 tolerances esta&lished for vario!s crops and crop gro!ps as well as $ederal $ood@ Dr!g@ and Cosmetic #ct G6/. tolerances for processed food and animal feed and animal tolerances. # re"assessment of tolerances is incl!ded in this doc!ment and there are no ma(or changes in the previo!sly"esta&lished tolerances. St!dies show that glyphosate is no more than slightly toxic to &irds and is practically non"toxic to fish and honey&ees. However@ a toxic inert in glyphosate end !se prod!cts necessitates the la&elling of some
prod!cts Dtoxic to fishD since some glyphosate prod!cts are applied directly to a:!atic environments. The #gency does have concerns regarding the potential ha7ard to endangered plant species and the Ho!ston toad. However@ the #gency is not re:!iring any modification of !se or la&el changes in this doc!ment. # $ederal Register 4otice on the Endangered Species 'rotection 'lan and s!&se:!ent g!idance to registrants will impose appropriate expos!re mitigation meas!res for areas where endangered plant species and the Ho!ston toad may &e enco!ntered. In addition@ there have &een a n!m&er of reported incidents of spray drift damage to non"target crops. Spray drift st!dies are re:!ired as is a Tier II Hegetative Higor st!dy. These st!dies are not part of the target data &ase for reregistration of glyphosate. Before reregistering each prod!ct@ the #gency is re:!iring that prod!ct specific data in the areas of prod!ct chemistry and ac!te toxicology@ revised Confidential Statements of $orm!la@ and revised la&eling &e s!&mitted within eight =5> months of the iss!ance of this doc!ment. In an effort to red!ce the time@ reso!rces@ and n!m&er of animals needed to f!lfill the ac!te toxicology data re:!irements for glyphosate"containing end !se prod!cts@ the #gency has D&atchedD prod!cts considered to &e similar with respect to ac!te toxicity testing re:!irements. #fter reviewing these data and the revised la&els@ the #gency will determine whether to re"register a prod!ct &ased on whether or not that prod!ct meets the re:!irements in Section 0=c>=1> of $I$R#. End !se prod!cts containing glyphosate in com&ination with other active ingredients will not &e re"registered !ntil the Reregistration Eligi&ility Decisions for all active ingredients contained in that prod!ct are iss!ed and all the active ingredients contained in the prod!ct are also eligi&le for reregistration. However@ prod!ct specific data for these prod!cts are &eing called in at this time.
I(
INTRO$' TION
In +.55@ the $ederal Insecticide@ $!ngicide@ and Rodenticide #ct =$I$R#> was amended to accelerate the reregistration of prod!cts with active ingredients registered prior to 4ovem&er +@ +.56. The amended #ct provides a sched!le for the reregistration process to &e completed in nine years. There are five phases to the reregistration process. The first fo!r phases of the process foc!s on identification of data re:!irements to s!pport the reregistration of an active ingredient and the generation and s!&mission of data to f!lfill the re:!irements. The fifth phase is a review &y the 8.S. Environmental 'rotection #gency =referred to as Dthe #gencyD> of all data s!&mitted to s!pport reregistration. $I$R# Section 6=g>=,>=#> states that in 'hase 1 Dthe #dministrator shall determine whether pesticides containing s!ch active ingredient are eligi&le for registrationD &efore calling in data on prod!cts and either re"registering prod!cts or ta*ing Dother appropriate reg!latory action.D Th!s@ reregistration involves a thoro!gh review of the scientific data &ase !nderlying a pesticide<s registration. The p!rpose of the #gency<s review is to reassess the potential ha7ards arising from the c!rrently registered !ses of the pesticideI to determine the need for additional data on health and environmental effectsI and to determine whether the pesticide meets the Dno !nreasona&le adverse effectsD criterion of $I$R#. This doc!ment presents the #gency<s decision regarding the reregistration eligi&ility of the registered !ses of the isopropylamine salt and the sodi!m salt form!lations of glyphosate. Except where explicitly noted otherwise@ the term Dglyphosate@D when !sed in this doc!ment@ refers to either the technical acid or the isoproplyamine and sodi!m salts of glyphosate &!t does not cover the monoammoni!m salt prod!cts since the compo!nd was not incl!ded in the $ederal Register p!&lication of 9ist #. The doc!ment consists of six sections. Section I is the introd!ction. Section II descri&es glyphosate@ its !ses@ data re:!irements and reg!latory history. Section III disc!sses the h!man health and environmental assessment &ased on the data availa&le to the #gency. Section IH presents the reregistration decision for glyphosate. Section H disc!sses the reregistration re:!irements for glyphosate. $inally@ Section HI is the #ppendices which s!pport this Reregistration Eligi&ility Doc!ment. #dditional details concerning the #gency<s review of applica&le data are availa&le on re:!est.+
$ield
E'#<s reviews of data on the set of registered !ses considered for E'#<s analysis may &e o&tained from the perations Division =H-1/2C>@ ffice of 'esticide 'rograms@ E'#@ Cashington@ DC ,/62/.
'' '
II(
ASE O%ER%IE)
A( *emical O+er+ie, The following active ingredient=s> are covered &y this Reregistration Eligi&ility Doc!mentB Common 4ameB Chemical 4ameB C#S Registry 4!m&erB '' Chemical CodesB Empirical $orm!laB Trade 4amesB glyphosate 4"phosphonomethyl glycine 0526+".6"/ +/02/+ =isopropylamine salt> +/02/0 =sodi!m salt> C0 H5 4
1
'
Ro!nd!p@ Rodeo@ Shac*le
Basic 3an!fact!rerB 3onsanto Company 5// 4. 9ind&ergh Blvd. St. 9o!is@ 3 20+2B( 'se Profile The following is information on the c!rrent registered !ses with an overview of !se sites and application methods. # detailed ta&le of the !ses of glyphosate is given in #ppendix #. ChemicalB glyphosate@ isopropylamine salt her&icide
=+/02/+> Type of ChemicalB 3echanism of #ctionB
not *nown at this time@ &!t it appears to inhi&it the aromatic amino acid &iosynthesis pathway and may inhi&it or repress chlorismate m!tase and?or prephenate hydratase.
8se sitesB
gro!ps
and
#J8#TIC $ D CR 'B agric!lt!ral drainage systems@ irrigation systems@ la*es?ponds?reservoirs =with h!man or wildlife !se>@ streams?rivers?channeled water. #J8#TIC 4 4"$ D I4D8STRI#9B a:!atic areas?water@ drainage systems@ systems. #J8#TIC 4 4"$ D a:!atic areas?water 8TD RB sewage
$ RESTRKB conifer release@ forest plantings =reforestation programs>@ forest trees =all or !nspecified>. %REE4H 8SE $ D CR 'B greenho!ses"in !se. I4D R 4 4"$ DB greenho!se"empty. 8TD R RESIDE4TI#9B ho!sehold?domestic dwellings premises. o!tdoor
TERRESTI#9 $EED CR 'B alfalfa@ &arley@ &eans@ &!c*wheat@ corn@ grass forage?fodder?hay@ lentils@ millet =proso>@ nongrass forage?fodder?straw?hay@ oats@ past!res@ rye@ sorgh!m@ wheat. TERRESTRI#9 $ D CR 'B acerola =Cest Indies Cherry>@ apricot@ articho*e =Eer!salem>@ asparag!s@ atemoya@ avocado@ &anana@ &eech n!t@ &eets@ &lac*&erry@ &l!e&erry@ &oysen&erry@ &ra7il n!t@ &readfr!it =&readn!t>@ &roccoli@ &r!ssels spro!ts@ &!ttern!t@ ca&&age@ ca&&age =Chinese>@ caram&ola =(alea>@ carrot =incl!ding tops>@ cashew@ ca!liflower@ celery@ chard =swiss>@ cherimoya@ cherry@ chestn!t@ chicory@ cocoa@ coffee@ collards@ cran&erry@ cress =water>@ c!c!m&er@ c!rrant@ date@ dew&erry@ eggfr!it tree =canistel>@ eggplant@ elder&erry@ endive =escarole>@ fig@ fil&ert =ha7eln!t>@ garlic@ goose&erry@ go!rds@ gro!ndcherry =straw&erry
tomato?tomatillo>@ g!ava@ hic*ory n!t@ horseradish@ h!c*le&erry@ (a&otica&a@ (ac*fr!it@ *ale@ *item&illa =ceylon goose&erry>@ *iwi fr!it@ *ohlra&i@ lee*@ lett!ce@ litchi n!t@ logan&erry@ longan@ lo:!at@ macadamia n!t
=&!shn!t>@ mamey =mammee apple>@ mango@ marmalade&ox =genipapo>@ mayhaw =hawthorn>@ melons@ melons =cantalo!pe>@ melons =honeydew>@ melons =mango>@ m e l o n s = m ! s * > @ m e l o n s = w a t e r > @ m e l o n s w i n t e r =casa&a?crenshaw?honeydew?persian>@ m!stard@ nectarine@ o*ra@ olive@ onion@ papaya@ parsley@ passion fr!it@ peach@ pear@ pecan@ pepper@ persimmon@ pistachio@ plantain@ pl!m@ pomegranate@ pr!ne@ p!mp*in@ :!ince@ radish@ rasp&erry =&lac*@ red>@ rh!&ar&@ r!ta&aga@ sapodilla@ sapota =white>@ so!rsop@ spinach@ s:!ash =s!mmer>@ s:!ash =winter>@ s!gar apple =c!stard apple>@ sweet potato@ tamarind@ taro@ tea@ waln!t =English?&lac*>@ yam. TERRESTRI#9 $ D L $EED CR 'B agric!lt!ral fallow?idleland@ almond@ apple@ &arley@ &eans@ &eets =!nspecified>@ &!c*wheat@ calamondin@ citron =citr!s>@ citr!s hy&rids other than tangelo@ corn =!nspecified>@ corn =field>@ cotton =!nspecified>@ grapefr!it@ grapes@ *!m:!at@ lemon@ lentils@ lime@ millet proso =&roomcorn>@ m!stard@ oats@ orange@ parsnip@ pean!ts =!nspecified>@ peas =!nspecified>@ pineapple@ potato =white?irish>@ p!mmelo =shaddoc*>@ rape@ rice@ rice =wild>@ rye@ sorgh!m@ soy&eans =!nspecified>@ s!gar &eet@ s!garcane@ tangelo@ tangerines@ tomato@ triticale@ t!rnip@ wheat. TERRESTRI#9 L %REE4H 8SE 4 4"$ D CR 'B ornamental and?or shade trees@ ornamental woody shr!&s and vines. TERRESTRI#9 4 4"$ D CR 'B agric!lt!ral fallow?idleland@ agric!lt!ral rights"of"way?fencerows?hedgerows@ agric!lt!ral !nc!ltivated areas@ airports?landing fields@ christmas tree plantations@ golf co!rse t!rf@ ind!strial areas =o!tdoor>@ nonagric!lt!ral o!tdoor &!ildings?str!ct!res@ nonagric!lt!ral rights"of"way?fencerows?hedgerows@ nonagric!lt!ral!nc!ltivated areas?soils@ ornamental and?or shade trees@ ornamental lawns and t!rf@ ornamental woody sh!&s and vines@ paths?patios@ paved areas =private roads?sidewal*s>@ recreational areas@ !r&an areas. TERRESTRI#9 4 4"$ DL 8TD R RESIDE4TI#9B ornamental and?or shade trees@ ornamental her&aceo!s plants@ ornamental lawns and t!rf@ ornamental woody sh!&s and vines.
'estsB
many &roadleaf and grass weeds
$orm!lation types registeredB SI4%9E #CTIHE I4%REDIE4TB $orm 4ot Identified?9i:!id 10.1/ A glyphosate@ isopropylamine salt 6+.// A glyphosate@ isopropylamine salt $orm 4ot Identified?Solid -2.// A glyphosate@ isopropylamine salt 9i:!id"Ready to 8se +..-/ A glyphosate@ isopropylamine salt +5.0/ A glyphosate@ isopropylamine salt +1.5/ A glyphosate@ isopropylamine salt +.// A glyphosate@ isopropylamine salt /..2 A glyphosate@ isopropylamine salt /.1/ A glyphosate@ isopropylamine salt 3an!fact!ring 8se .6.// A glyphosate@ isopropylamine salt 'elleted?Ta&leted 50.1/ A glyphosate@ isopropylamine salt 2/.// A glyphosate@ isopropylamine salt 'ress!ri7ed 9i:!id /..2 A glyphosate@ isopropylamine salt /.-1 A glyphosate@ isopropylamine salt Sol!&le Concentrate?9i:!id 2,.// A glyphosate@ isopropylamine salt 10.5/ A glyphosate@ isopropylamine salt 6+.1/ A glyphosate@ isopropylamine salt 6+.// A glyphosate@ isopropylamine salt ,5.2/ A glyphosate@ isopropylamine salt ,1.+/ A glyphosate@ isopropylamine salt +5.// A glyphosate@ isopropylamine salt +/.// A glyphosate@ isopropylamine salt 5.,/ A glyphosate@ isopropylamine salt -.// A glyphosate@ isopropylamine salt 1.// A glyphosate@ isopropylamine salt Sol!&le Concentrate?Solid .0..2 A glyphosate@ isopropylamine salt
389TI'9E #CTIHE I4%REDIE4TB 9i:!id"Ready to 8se +,.6/ A glyphosate@ isopropylamine salt L + other #.I. -.-/ A glyphosate@ isopropylamine salt L + other #.I. /.1/ A glyphosate@ isopropylamine salt L + other #.I. /.,1 A glyphosate@ isopropylamine salt L + other #.I. Sol!&le Concentrate?9i:!id +2.1/ A glyphosate@ isopropylamine salt L + other #.I. +6.5/ A glyphosate@ isopropylamine salt L + other #.I. +0.0/ A glyphosate@ isopropylamine salt L + other #.I. +,../ A glyphosate@ isopropylamine salt L + other #.I. 3ethods and rates of application =%iven in maxim!m active =acid e:!ivalent =ae>> rates@ except as otherwise noted>B Broadcast or sprayI for example as neededB $orm 4ot Identified?9i:!id " rates were not specified in #ppendix # dated 5?+,?.0I $orm 4ot Identified?Solid " rates were not specified in #ppendix # dated 5?+,?.0I 9i:!id"Ready to 8se " applied at rate of 0./5 l& ae?#I 'elleted?Ta&leted " applied as a spot treatment@ for example from a hand held sprayerI 'ress!ri7ed 9i:!id " applied as a spot treatment@ for example from an aerosol canI Sol!&le Concentrate?9i:!id " applied at rate of -.1 l& ae?#I Sol!&le Concentrate?Solid " applied at rates of /./. gal ae?#I ChemicalB glyphosate@ sodi!m salt plant reg!lator
=+/02/0> Type of ChemicalB 3echanism of #ctionB
modifies plant growthI hastens fr!it ripening
8se %ro!ps and SitesB TERRESTRI#9 $ D L $EED CR 'B pean!ts =!nspecified>I s!garcane $orm!lation Types RegisteredB SI4%9E #CTIHE I4%REDIE4TB sol!&le concentrate?solid -1./A glyphosate@ sodi!m salt 3ethods and Rates of #pplicationB sol!&le concentrate?solid " applied as gro!nd spray at pean!t &loom stage at /./0-1 l& a.i.?# in +/ gal waterI sol!&le concentrate?solid " applied as aerial spray at s!garcane ratoon stage at /.1,1 l& a.i.?# in 1 gal water. 8se 9imitationsB s!garcane " ,+ days preharvest intervalI pean!ts " 56 days preharvest interval. Do not apply this prod!ct thro!gh any type of irrigation system. ( Estimated 'sage of Pesticide This section s!mmari7es the &est estimates availa&le for the pesticide !ses of glyphosate. These estimates are derived from a variety of p!&lished and proprietary so!rces availa&le to the #gency. The data@ reported on an aggregate and site =crop> &asis@ reflect ann!al fl!ct!ations in !se patterns as well as the varia&ility in !sing data from vario!s information so!rces. The ta&le &elow s!mmari7es glyphosate !seage &y site. Glyphosate Usage
Site Multiple Acres Treated (x1000) unknown 350-390 Pounds AI (x1000) 3000-7000 500-550
non-ag areas almonds
apples barley cherries corn, ield co!!on hay"pas!ure dry edible beans"peas grape rui! grapes lemons o!her ag si!es oranges peaches peanu!s pears pecans plums"prunes rice sorghum soybeans spring whea! sugarcane po!a!oes sun lowers swee! corn !oma!oes green beans"peas walnu!s win!er whea!
75-275 550-600 15-95 1,300-1,700 300-1,000 3,000-3,500 50 70-1#0 #5-550 5-75 3,000-3,500 300-600 10-150 10-30 15-50 5-300 5-$0 30-55 #50-550 2,600-#,$00 200-225 10-70 20-#0 60-70 10-30 30-#0 20-#0 150-175 350-1,150
65-200 275-325 20-125 1,100-1,200 225-375 1,500-1,700 20 1$3-375 25-265 10-70 1,000-1,500 650-1,300 10-110 5-10 15-65 5-150 5-#0 25-30 100-150 2,200-2,#00 50-60 5-35 25-30 25-#0 5-15 15-30 5-20 100-125 250-#50
TOTA
1!"#$%&!0"!$0
11"'#$&1$"()%
In a typical year &etween +.5. and +..+@ approximately +0",/ million acre treatments were made with +5.- million po!nds active ingredient. Hay?past!re =,/A>@ soy&eans =,/A>@ field corn =.A>@ and other agric!lt!ral areas =,/A> comprise -+A of the total acreage treated with glyphosate. 4on" agric!lt!ral areas =00A>@ soy&eans =+1A>@ hay?past!re =++A>@ and corn =5A> comprise 2-A of the total po!nds of active ingredient applied. $( $ata Re-!irements Data re:!ired in the E!ne +.52 Registration Standard for glyphosate incl!de st!dies on prod!ct chemistry@ ecological effects@ environmental fate@ toxicology@ and resid!e chemistry. These data were re:!ired to s!pport the !ses listed in the Registration Standard. #ppendix B incl!des all data re:!irements identified &y the #gency for c!rrently registered !ses needed to s!pport reregistration. E( Reg!lator. Histor. %lyphosate is registered in the 8nited States for !se as a her&icide. The E!ne +.52 Registration Standard eval!ated the st!dies c!rrently on file at the #gency and re:!ired s!&mission of f!rther data. This Reregistration Eligi&ility Doc!ment reflects an assessment of all data which were s!&mitted in response to the Registration Standard.
III(
S IEN E ASSESSMENT
A( Prod!ct *emistr.
Empirical $orm!laB 3olec!lar CeightB C#S Registry 4o.B Sha!ghnessy 4o.B
C 0 H5 4 1 ' +2../0526+".6"/ +/02/+ =isopropylamine salt@ I'#> +/02/0 =sodi!m salt>
The glyphosate =4"phosphonomethyl glycine> salts are nonselective her&icides and plant growth reg!lators. The technical isopropylamine salt =I'#> is a white crystalline solid with a melting point of ,//EC and a &!l* density of +.-6 l&?ft0. It is +A sol!&le in water at ,1EC and insol!&le in ethanol@ acetone@ or &en7ene. The technical sodi!m salt is a white crystalline solid which decomposes at +6/EC with a &!l* density of 0/ l&?ft0 . B( H!man Healt* Assessment +. Toxicology #ssessment The toxicological data &ase on glyphosate is ade:!ate and will s!pport reregistration eligi&ility. a. #c!te Toxicity The ta&le &elow s!mmari7es the toxicity res!lts and categories for technical grade glyphosate. The ac!te inhalation st!dy was waived &y the #gency since glyphosate technical is a nonvolatile solid and ade:!ate inhalation st!dies were cond!cted on the end"!se prod!ct form!lations. Acute Toxicity
Test %cu!e &ral 'ra!( '1( %cu!e +ermal 'rabbi!('1( %cu!e *nhala!ion '1( 1 - /-*+ 00067039 *esult ) #320 mg"kg ) 2 g"kg ,o! -e.uired +ategory *** *** ,"%
The following ta&le is derived from 3's considered toxicologically similar to glyphosate technical.
Acute Toxicity
Test 0ye *rri!a!ion '1( +ermal *rri!a!ion '2( 2kin 2ensi!i3a!ion '3( *esult mild irri!a!ion, clears in 7 days sligh! irri!a!ion nega!ive +ategory *** *1 ,"%
1 - /-*+ #1#00603 2 - /-*+ #1#0060# 3 - /-*+s 00137137, 0013713$, 00137139, 001371#0
ther st!dies s!&mitted to the #gency give similar res!lts. They are accepta&le for reregistration =3RIDs 6+6//2/+@ and 6+6//2/,> &. S!&chronic Toxicity In a ./"day feeding st!dy Sprag!e"Dawley rats were fed diets containing /@ +///@ 1/// or ,//// ppm of glyphosate for three months. These doses were e:!ivalent to /@ 20@ 0+- and +,2- mg?*g?day@ respectively =males> and /@ 56@ 6/6 and +2,0 mg?*g?day@ respectively =females>. The following findings were regarded as possi&ly treatment"relatedB =+> increased ser!m phosphor!s and potassi!m in all treated gro!ps@ males and femalesI =,> increased ser!m gl!cose in the mid"dose and high" dose malesI =0> increased &lood !rea nitrogen =B84> and ser!m al*aline phosphatase in the high"dose malesI and =6> occ!rrence of pancreatic lesions in the high"dose males =pancreas was not examined in the low"dose and mid"dose gro!ps>. Based on these findings@ the systemic 4 E9 is M +/// ppm =not determined definitively> for &oth sexes. =3RIDs 6/11.6/+@ and ///.05-.> In a second ./"day feeding st!dy CD"+ mice were fed diets containing /@ ,1/@ 1// or ,1// mg?*g?day of glyphosate for three months. Body weight gains of the high"dose males and females were a&o!t ,6A and +5A lower@ respectively@ than those of the controls. Body weight gains of the low"dose and mid"dose gro!ps were compara&le to those of the controls. Based on the red!ced
&ody weight gains in &oth sexes@ the 4 E9 for systemic toxicity is 1// mg?*g and the 9 E9 is ,1// mg?*g. =3RID ///025/0> In a ,+"day dermal st!dy glyphosate was applied to the s*in of 4ew Nealand white ra&&its !sing +/ ra&&its?sex?dose =1 with intact and 1 with a&raded s*in>. The levels of glyphosate tested were +/@ +/// or 1/// mg?*g?day. The ra&&its were exposed for three consec!tive wee*s@ 2 ho!rs?day@ 1 days?wee*. Treatment"related effects o&served only in the high dose gro!ps incl!dedB =+> very slight erythema and edema in intact and a&raded s*in of &oth sexesI =,> decreased food cons!mption in malesI and =0> decreased ser!m lactic dehydrogenase in &oth sexes. Based on these effects@ the 4 E9 for males and females is +/// mg?*g?day and the 9 E9 is 1/// mg?*g?day. =3RID ///.562/> The re:!ired ./"day feeding st!dy in dogs is satisfied &y the one"year dog feeding st!dy. =3RID //+100-6> c. Chronic Toxicity # chronic feeding?carcinogenicity st!dy was cond!cted !sing male and female Sprag!e"Dawley rats which were fed diets containing /@ 0/@ +// or 0// ppm of glyphosate for ,2 months. These levels were e:!ivalent to /@ 0@ +/ and 0+ mg of glyphosate?*g?day@ respectively@ for the males and /@ 0@ ++ and 06 mg of glyphosate?*g?day@ respectively@ for the females. There were no effects &ased on any of the parameters examined =toxic signs@ mortality@ &ody weights@ food cons!mption@ hematology@ clinical chemistry@ !rinalysis@ organ weights and organ?tiss!e pathology>. Therefore@ the 4 E9 for systemic toxicity is $ 0// ppm =HDTI malesB 0+ mg?*g?day and femalesB 06 mg?*g?day>. =3RID ///.05-.> # second chronic feeding?carcinogenicity st!dy was cond!cted !sing male and female Sprag!e"Dawley rats which were fed diets containing /@ ,///@ 5/// or ,//// ppm of glyphosate for , years. These levels were e:!ivalent to /@ 5.@ 02, or .6/ mg?*g?day@ respectively@ for the males and /@ ++0@ 61- or ++50
mg?*g?day@ respectively@ for the females. Treatment"related effects o&served only in the high"dose gro!p incl!dedB =+> In the femalesB decreased &ody weight gainsI and =,> In the malesB increased incidence of cataracts and lens a&normalities@ decreased !rinary
pH@ increased a&sol!te liver weight and increased liver weight?&rain weight ratio =relative liver weight>. 4o significant systemic effects were o&served in the low"dose and mid"dose male and female gro!ps. Therefore@ the 4 E9 for systemic toxicity is 5/// ppm =malesB 02, mg?*g?day and femalesB 61mg?*g?day> and the 9 E9 is ,//// ppm =HDTI malesB .6/ mg?*g?day and femalesB ++50 mg?*g?day>. =3RID 6+2605/+> # chronic st!dy was cond!cted !sing male and female &eagle dogs which were given glyphosate in gelatin caps!les containing /@ ,/@ +// or 1// mg?*g?day for one year. There were no effects &ased on all parameters examined@ in all gro!ps. Therefore@ the 4 E9 for systemic toxicity is $ 1// mg?*g?day@ for &oth sexes. =3RID //+100-6> d. Carcinogenicity # chronic feeding?carcinogenicity st!dy was cond!cted !sing Sprag!e"Dawley rats which were fed diets containing glyphosate =malesB /@ 0@ +/ or 0+ mg?*g?day and femalesB /@ 0@ ++ or 06 mg?*g?day> for ,2 months. The following findings were o&served in the high"dose gro!ps when compared with the conc!rrent controlsB =+> increased incidence of thyroid C"cell carcinomas in femalesI and =,> increased incidence of interstitial cell =9eydig cell> testic!lar t!mors. However@ the #gency concl!ded that these neoplasms were not treatment"related and glyphosate was not considered to &e carcinogenic in this st!dy &eca!se the incidence of thyroid carcinomas was not statistically significant and the incidence of testic!lar t!mors was within the historical incidence. The #gency also concl!ded that this st!dy was not cond!cted at high eno!gh dose levels for an ade:!ate negative carcinogenicity. =3RID ///.05-.> # chronic feeding?carcinogenicity st!dy was cond!cted !sing Sprag!e"Dawley rats fed diets containing glyphosate =malesB /@ 5.@ 02, or .6/ mg?*g?day and femalesB /@ ++0@ 61- or ++50 mg?*g?day> for , years. The st!dy showed a slightly increased incidence of =+> pancreatic islet cells adenomas in the low"dose and high"dose malesI =,> hepatocell!lar =liver> adenomas in the low"dose and high" dose malesI and =0> thyroid C"cells
adenomas in the mid"dose and high"dose males and females. The #gency concl!ded that these
adenomas were not treatment"related and glyphosate was not considered to &e carcinogenic in this st!dy. Cith respect to pancreatic islet cells adenomas@ there was no statistically significant positive dose"related trend in their occ!rrenceI there was no progression to carcinomasI and the incidence of pancreatic hyperplasia =non"neoplastic lesion> was not dose" related. Cith respect to hepatocell!lar adenomas@ the increased incidence of these neoplasms was not statistically significant in comparison with the controlsI the incidence was within the historical control rangeI there was no progression to carcinomasI and the incidence of hyperplasia was not compo!nd"related. Cith respect to thyroid C" cell adenomas@ there was no statistically significant dose"related trend in their occ!rrenceI the increased incidence was not statistically significantI there was no progression to carcinomasI and there was no significant dose"related increase in severity or incidence of hyperplasia in either sex. =3RID 6+2605/+> # carcinogenicity st!dy in mice was cond!cted with CD"+ mice fed diets containing /@ +1/@ -1/ or 61// mg?*g?day of glyphosate for +5 months. 4o effects were o&served in the low" dose and mid"dose gro!ps. The following findings were o&served in the high"dose gro!pB =+> decreased &ody weight gain in males and femalesI =,> increased incidence of hepatocell!lar hypertrophy@ hepatocell!lar necrosis and interstitial nephritis in malesI =0> increased incidence of proximal t!&!le epithelial &asophilia and hypertrophy in femalesI and =6> slightly increased incidence of renal t!&!lar adenomas@ a rare t!mor@ in males. Based on these effects@ the systemic 4 E9 and 9 E9 were -1/ mg?*g?day and 61// mg?*g?day@ respectively. The #gency concl!ded that the occ!rrence of these adenomas was spontaneo!s rather than compo!nd"ind!ced &eca!se the incidence of renal t!&!lar adenomas in males was not statistically significant when compared with the conc!rrent controls. #n independent gro!p of pathologists and &iometricians also cond!cted extensive eval!ations of these adenomas and reached the same concl!sion. Therefore@ glyphosate was not considered to &e carcinogenic in this st!dy. =3RIDs //+0/6/2@ and //+1/126> n E!ne ,2@ +..+@ the #gency classified glyphosate in %ro!p E =evidence of non"carcinogenicity for h!mans>@ &ased on a lac* of convincing evidence of carcinogenicity in ade:!ate
st!dies with two animal species@ rat and mo!se.
e.
Developmental Toxicity # developmental toxicity st!dy was cond!cted with pregnant Charles River C BS CD rats which were administered /@ 0//@ +/// or 01// mg?*g?day of glyphosate &y gavage d!ring gestation days 2 thro!gh +.. Treatment"related effects o&served only in the high" dose dams incl!dedB =+> diarrheaI =,> decreased mean &ody weight gainI =0> &reathing rattlesI =6> inactivityI =1> red matter aro!nd the nose and mo!th@ and on forelim&s and dorsal headI =2> decreases in total implantations?dam and invia&le fet!ses?damI and =-> deaths =2?,1 or ,6A of the gro!p>. Treatment"related developmental effects o&served only in the high"dose gro!p incl!dedB =+> increased n!m&er of litters and fet!ses with !nossified sterne&raeI and =,> decreased mean fetal &ody weights. Therefore@ the 4 E9 and 9 E9 for maternal toxicity are +/// mg?*g?day and 01// mg?*g?day@ respectively. The 4 E9 and 9 E9 for developmental toxicity are +/// mg?*g?day and 01// mg?*g?day@ respectively. =3RID ///6202,> In a second st!dy@ pregnant D!tch Belted ra&&its were administered /@ -1@ +-1 or 01/ mg?*g?day of glyphosate &y gavage d!ring gestation days 2 thro!gh ,-. Treatment"related findings were o&served only in the high"dose gro!p and incl!dedB =+> diarrheaI =,> nasal dischargeI and =0> death =+/?+2 or 2,.1A of does died &y gestation day ,+>. Developmental toxicity was not o&served at any dose tested. Therefore@ the 4 E9 and 9 E9 for maternal toxicity are +-1 mg?*g?day and 01/ mg?*g?day@ respectively. The 4 E9 for developmental toxicity is $ +-1 mg?*g?day. D!e to high maternal mortality at the 01/ mg?*g?day dose level@ too few litters =only 2> were availa&le to assess ade:!ately developmental toxicity at that level. =3RID ///62020>
f.
Reprod!ctive Toxicity # reprod!ction st!dy was cond!cted with male and female Sprag!e"Dawley rats which were administered /@ 0@ +/ or 0/ mg?*g?day of glyphosate contin!o!sly in the diet for three s!ccessive generations. The only effect o&served was an increased incidence of focal t!&!lar dilation of the *idney =&oth !nilateral and &ilateral com&ined> in the high"dose male $ 0& p!ps. Therefore@ the 4 E9 for systemic and reprod!ctive toxicity
is $ 0/ mg?*g?day =HDT>. The
4 E9 and 9 E9 for developmental toxicity are +/ mg?*g?day and 0/ mg?*g?day@ respectively. =3RID //+/1..1> #nother reprod!ction st!dy was cond!cted with Sprag!e" Dawley rats which were administered /@ +//@ 1// or +1// mg?*g?day of glyphosate contin!o!sly in the diet for two s!ccessive generations. Treatment"related effects o&served only in the high" dose gro!p incl!dedB =+> soft stools@ very fre:!ent@ in the $ o and $ + males and femalesI =,> decreased food cons!mption and &ody weight gain of the $ o and $+ males and females d!ring the growth =premating> periodI and =0> decreased &ody weight gain of the $ +a@ $,a and $,& male and female p!ps d!ring the second and third wee*s of lactation. $ocal t!&!lar dilation of the *idneys@ o&served in the previo!s st!dy =//+/1..1>@ was not o&served at any dose level in this st!dy. Based on the a&ove findings@ the systemic 4 E9 and 9 E9 are +//// ppm =1// mg?*g?day> and 0//// ppm =+1// mg?*g?day>@ respectively. The reprod!ctive 4 E9 is 0//// ppm =+1// mg?*g?dayI HDT>I and the developmental 4 E9 and 9 E9 are +//// ppm =1// mg?*g?day> and 0//// ppm =+1// mg?*g?day>@ respectively. =3RID 6+2,+1/+> Since the focal t!&!lar dilation of the *idneys was not o&served at the +1// mg?*g?day level =HDT> in the ,"generation rat reprod!ction st!dy &!t was o&served at the 0/ mg?*g?day level =HDT> in the 0"generation rat reprod!ction st!dy =//+/1..1>@ the #gency concl!ded that the latter was a sp!rio!s rather than glyphosate"related effect.
g.
3!tagenicity # %ene m!tation assay in an #mes Test was cond!cted !sing glyphosate@ &oth with and witho!t meta&olic activation. The strains of Salmonella typhimurium !sed were T#.5@ T#+//@ T#+101 and T#+10-. 4o increases in reverse m!tations were o&served at any concentration. =3RID ///-52,/> # gene m!tation assay in mammalian cells was cond!cted !sing glyphosate in the Chinese hamster ovary =CH > cells?hypoxanthine " g!anine "phosphori&osyl transferase =H%'RT> assay@ with and witho!t meta&olic activation. 4o m!tagenic response was o&served either with or witho!t meta&olic activation !p to the limit of cytotoxicity =+/ mg?3l>. =3RID //+0,25+> # Str!ct!ral Chromosomal #&erration #ssay was cond!cted !sing a single dose of glyphosate administered intraperitoneally =i.p.> to male and female Sprag!e"Dawley rats. The dose !sed was + g?*g of &ody weight and the &one marrow cells were examined for clastogenic =chromosome"damaging> effect. 4o significant clastogenic effects were o&served. =3RID //+0,250> In a fo!rth st!dy@ glyphosate was tested in two assaysB the rec"assay !sing !. su$tilis H+- =recL> and 361 =rec">I and the reverse m!tation assays !sing E. coli C', hc r and Salmonella typhimurium strains T#.5@ T#+//@ T#+101@ T#+10and T#+105@ with and witho!t meta&olic activation. 4o increases in m!tations were o&served in either st!dy. =3RID ///-52+.>
h.
3eta&olism Two meta&olism st!dies with rats are availa&le. In the first st!dy@ single or repeated doses of radiola&eled +6C"glyphosate were administered orally to male and female Sprag!e"Dawley rats. $ollowing a single oral dose of +6 C"glyphosate@ 0/ to 02A of the dose was a&sor&ed and less than /.,-A of the dose was eliminated as C , . 4inety"seven point five percent of the administered dose was excreted in the !rine and feces as the parent compo!nd@ glyphosate. #mino methyl phosphonic acid =#3'#> was the only meta&olite fo!nd in !rine =/.,"/.0A of the
administered dose> and feces =/.,"/.6A of the administered dose>. 9ess than +./A of the
a&sor&ed dose remained in tiss!es and organs@ primarily in &one tiss!e. Repeated dosing at +/ mg?*g did not significantly change the meta&olism@ distri&!tion or excretion of glyphosate. =3RIDs 6/-2-+/+@ and 6/-2-+/,> In a second st!dy@ male and female Sprag!e"Dawley rats received single intraperitoneal in(ections of radiola&eled +6C" glyphosate. The dose level of glyphosate !sed for male and female rats was ++1/ mg?*g. Blood samples were collected /.,1@ /.1/@ +@ ,@ 6@ 2 and +/ ho!rs after in(ection. $emoral &one marrow samples were collected from one third of the male and female rats sacrificed at /.1@ 6@ or +/ ho!rs after in(ection. Thirty min!tes after in(ection of glyphosate@ the concentration of radioactivity in the &one marrow of male and female rats was e:!ivalent to /.//66A and /.//-,A@ respectively@ of the administered dose. #ss!ming first order *inetics@ the decrease in radioactivity in &one marrow occ!rred with a half"life of -.2 and 6., ho!rs for males and females@ respectively. Similarly@ the half"lives of the radioactivity in plasma were approximately + ho!r for &oth sexes. These findings indicate that very little glyphosate reaches &one marrow@ that it is rapidly eliminated from &one marrow and that it is even more rapidly eliminated from plasma. =3RID //+0,251> i. 4e!rotoxicity The ac!te and ./"day ne!rotoxicity screening &attery in the rat =g!idelines 5+"5"SS@ 5,"-> is not &eing re:!ired since there was no evidence of ne!rotoxicity seen in any of the existing st!dies at very high doses and this chemical lac*s a leaving gro!pI therefore@ it wo!ld not seem li*ely to inhi&it esterases =the pres!mptive ne!rotoxic mechanism of concern for all organophosphates>.
(.
ther Toxicological Endpoints # dermal penetration st!dy =g!ideline 51",> with technical grade glyphosate is not &eing re:!ired &eca!se there are no toxicological endpoints to indicate this st!dy is necessary. Domestic #nimal Safety St!dies =52"+> are not &eing re:!ired for the !se patterns of glyphosate =a plant growth reg!lator and her&icide>. Technical grade glyphosate contains 4"nitrosoglyphosate =44%> as a contaminant. Carcinogenicity testing of nitroso contaminants is normally re:!ired only in those cases in which the level of nitroso compo!nds exceeds +./ ppm. #nalyses showed that greater than .,A of the individ!al technical glyphosate samples contained less than +./ ppm 44%. The #gency concl!ded that the 44% content of glyphosate was not toxicologically significant.
*.
Reference Dose n #!g!st ,-@ +..,@ the #gency<s ffice of 'esticide 'rograms Reference Dose =RfD> 'eer Review Committee recommended that the RfD for glyphosate &e esta&lished at , mg?*g?day. This val!e was &ased on the maternal 4 E9 of +-1 mg?*g?day from the ra&&it developmental toxicity st!dy =///62020> and an !ncertainty factor =8$> of +//. This RfD has not yet &een confirmed &y the #gency RfD Cor* %ro!p. In Septem&er of +.52@ the Eoint $ood and #gric!lt!ral rgani7ation of the 8nited 4ations =$# >?Corld Health rgani7ation =CH > on 'esticides Resid!es OE3'RP proposed an #llowa&le Daily Inta*e =#DI> of /.0 mg?*g &ody weight for glyphosate per se. The #DI was &ased on a ,2"month feeding st!dy in the rat yielding a 4 E9 of Q 0+ mg?*g &ody weight per day and and !ncertainty factor of +//. The #gency places more importance on the developmental ra&&it st!dy since no effect was o&served in the ,2" month st!dy whereas maternal mortality was o&served in the developmental ra&&it st!dy in the high dose gro!p. E3'R
ac*nowledged that there is no effect at the highest dose tested in the ,2"month rat st!dy. ,. Expos!re #ssessment a. Dietary Expos!re The :!alitative nat!re of the resid!e in plants is ade:!ately !nderstood. St!dies with a variety of plants incl!ding corn@ cotton@ soy&eans@ and wheat indicate that the !pta*e of glyphosate or its meta&olite@ aminomethyl phosphonic acid =#3'#>@ from soil is limited. The material which is ta*en !p is readily translocated. $oliarly applied glyphosate is readily a&sor&ed and translocated thro!gho!t the trees or vines to the fr!it of apples@ coffee@ dwarf citr!s =calamondin>@ pears and grapes. 3eta&olism via 4" methylation yields 4"methylated glycines and phosphonic acids. $or the most part@ the ratio of glyphosate to #3'# is . to + &!t can approach + to + in a few cases =e.g.@ soy&eans and carrots>. 3!ch of the resid!e data for crops reflects a detecta&le resid!e of parent =/./1 " /.+1 ppm> along with resid!es &elow the level of detection =M/./1 ppm> of #3'#. The terminal resid!e to &e reg!lated in plants is glyphosate per se. The :!alitative nat!re of the resid!e in animals is ade:!ately !nderstood. St!dies with lactating goats and laying hens fed a mixt!re of glyphosate and #3'# indicate that the primary ro!te of elimination was &y excretion =!rine and feces>. These res!lts are consistent with meta&olism st!dies in rats@ ra&&its@ and cows. The terminal resid!es in eggs@ mil*@ and animal tiss!es are glyphosate and its meta&olite #3'#I there was no evidence of f!rther meta&olism. The terminal resid!e to &e reg!lated in livestoc* is glyphosate per se. #n ade:!ate enforcement method is availa&le for analysis of resid!es of glyphosate and its meta&olite #3'# in or on plant commodities and in water. This method !tili7es %9C =3ethod I of '#3 Hol. III limit of detection is /./1 ppm>. $or enforcement of tolerances in animal commodities@ an H'9C method with fl!orescence detection is availa&leI the reported limits of detection are /./+ ppm for glyphosate and /./+, ppm for #3'#.
The availa&le storage sta&ility data indicate that resid!es of glyphosate and its meta&olite #3'# are sta&le !nder fro7en storage conditions =",/EC>B in or on plant commodities for a period of + year@ in animal commodities for , years@ and in water for + year. 4o additional storage sta&ility data are needed. #ll data re:!irements for magnit!de of the resid!e in plants have &een eval!ated and deemed ade:!ate. #dditional potato processing data are &eing generated. #ll data re:!irements for magnit!de of the resid!e in plants as a res!lt of irrigation with glyphosate"treated water have also &een s!&mitted and are ade:!ate to s!pport registered !se and applica&le tolerances. 4o additional data are re:!ired for magnit!de of the resid!e in animals@ pota&le water@ and fish. # list of resid!e chemistry st!dy references is provided on page ,6. &. cc!pational and Residential cc!pational and residential expos!re can &e expected &ased on the c!rrently registered !ses of prod!cts containing glyphosate. However@ d!e to the low toxicity =ac!te category III> of glyphosate and the lac* of other toxicological concerns =i.e carcinogenicity> occ!pational and residential expos!re data are not re:!ired. %lyphosate is a non"selective her&icide applied to terrestrial food and non"food crops@ t!rf@ greenho!se crops@ and non" crop areas where total vegetation control is desired. %lyphosate@ when applied at lower rates@ is also a plant growth reg!lator. #ltho!gh glyphosate meets the #gency<s expos!re criteria for post"application?reentry and?or mixer?loader?applicator expos!re monitoring data@ glyphosate does not meet the #gency<s toxicity criteria for these data re:!irements. #c!te oral and dermal toxicity data for the technical material are in Toxicity Category III and IH. In addition@ glyphosate is poorly a&sor&ed dermally. The ac!te inhalation toxicity st!dy for the technical material was waived &eca!se glyphosate is non"volatile and &eca!se there were ade:!ate inhalation st!dies with end"!se prod!cts showing low toxicity. Therefore@ occ!pational and residential expos!re data are not re:!ired to s!pport the reregistration of glyphosate. =$or these
same reasons@ these data were not re:!ired in the +.52 Registration Standard.> The following information is prod!ct"specific related@ &!t is presented here for informational p!rposes. Some glyphosate end" !se prod!cts are in Toxicity Category I and II &ased on primary eye irritation or dermal irritation. In California@ where physicians are re:!ired to report pesticide poisonings@ glyphosate was ran*ed third o!t of the ,1 leading ca!ses of illnesses or in(!ry d!e to pesticides !sed &etween +.5/ and +.56. These mixer?loader?applicator reported incidents consisted of eye and s*in irritation. In reports iss!ed &y California since then =+.5and +.55>@ glyphosate contin!ed to &e a leading ca!se of illnesses or in(!ries =primarily eye and s*in irritation>. In the +.52 Registration Standard@ the #gency recommended personal protective e:!ipment@ incl!ding protective eyewear for mixer?loader?applicators !sing end"!se prod!cts that co!ld ca!se eye or s*in irritation. #t that time@ it was determined that mixer?loaders were at ris* of eye or s*in in(!ry from splashes d!ring mixing and loading. The #gency did not re:!ire personal protective e:!ipment for !sers of DhomeownerD prod!cts =containing !p to +/A glyphosate> &eca!se of the low concentration of glyphosate and &eca!se the prod!cts are Dready"to"!seD@ re:!iring no mixingI therefore@ the potential for eye or dermal expos!re is minimi7ed. The #gency@ at this time@ is not adding any additional personal protective e:!ipment re:!irements to the la&els of end" !se prod!ctsI however@ any existing personal protective e:!ipment on those la&els m!st &e retained. The Cor*er 'rotection Standard =C'S> for #gric!lt!ral 'esticides "" 6/ C$R 'arts +12 and +-/ "" esta&lished an interim restricted entry interval =REI> of +, ho!rs for glyphosate &eca!se the ac!te toxicity categories of glyphosate for ac!te dermal toxicity@ s*in irritation potential@ and eye irritation potential are Toxicity Category III or IH. The #gency has determined that the +,"ho!r REI for all C'S sites sho!ld &e retained as a pr!dent meas!re to mitigate ris* to wor*ers entering treated areas after application. $!rthermore@ given the *nown irritation" effects concerns for glyphosate@ the #gency considers the additional protections offered &y the re:!irements in the C'S essential to its decision that a +,"ho!r REI for this chemical will
offer s!fficient ris* mitigation to wor*ers.
Therefore@ d!ring the REI the #gency will allow wor*ers to enter areas treated with glyphosate d!ring the REI only in the few narrow exceptions allowed in the C'S. The #gency has determined that@ at this time@ the entry restrictions disc!ssed in this section need not apply to !ses of glyphosate o!side the scope of the Cor*er 'rotection Standard for #gric!lt!ral Chemicals@ incl!ding o!t"of"scope commercial !ses and homeowner !ses. The predicted fre:!ency@ d!ration@ and degree of expos!re d!e to post"application as the res!lt of s!ch !ses sho!ld not warrant the ris* mitigation meas!res &eing re:!ired for persons engaged in the prod!ction of agric!lt!ral plants for commercial or research p!rposes. 0. Ris* #ssessment a. Dietary The chronic dietary ris* analysis !sed tolerance level resid!es and ass!med all acreage@ of the crops considered@ was treated with glyphosate to estimate the Theoretical 3axim!m Resid!e Contri&!tion =T3RC> for the overall 8.S. pop!lation and ,, pop!lation s!&gro!ps. These expos!res =T3RCs> were then compared to the RfD for glyphosate to estimate chronic dietary ris*. The calc!lated T3RC for the overall 8.S. pop!lation from food !ses of glyphosate is /./,1 mg?*g &wt?day@ which represents +.,A of the RfD. The s!&gro!p most highly exposed@ non"n!rsing infants less than one year old@ has a T3RC of /./15 mg?*g &wt?day@ or ,..A of the RfD. ver one third of the dietary expos!re and ris* from glyphosate is d!e to the proposed tolerances on wheat. This analysis was meant to &e a Dworst caseD scenario of ris*. The incl!sion of recommended tolerances for reregistration as well as tolerances recommended for revocationI the !se of the highest existing@ pending@ or recommended resid!e val!e for each commodityI and the ass!mptions of tolerance level resid!es and treatment of +// percent of the crops for every commodity considered res!lt in an overestimation of expos!re and ris* val!es for glyphosate =tho!gh there is some
!nderestimation d!e to the lac* of cons!mption information for some of the commodities to which
glyphosate is expected to &e applied>. 4onetheless@ given the ris* val!es arrived at &y this analysis@ E'# concl!des that the chronic dietary ris* posed &y this pesticide on these food !ses is minimal. &. cc!pational and Residential #s disc!ssed a&ove in the occ!pational expos!re assessment@ expos!re to h!mans from proper application of glyphosate to terrestrial food and non"food crops as well as greenho!ses@ t!rf@ and non"crop areas can res!lt in in(!ry =primarily eye and s*in irritation> from splashes d!ring mixing and loading. The #gency contin!es to recommend protective clothing =incl!ding protective eye wear> for mixer?loader?applicators !sing end"!se prod!cts that may &e in toxicity category I or II for primary eye and dermal irritation. c. Dietary Expos!re References This ta&le references the resid!e data !sed to s!pport the reregistration of glyphosate and incl!des the commodities eligi&le for reregistration.
4uideline"5ommodi!y 6171-# 'a(7 8lan! /e!abolism
-e erences 1 0003$771, 000391#1, 000519$3, 00065753, 0010$097, 0010$129, 0010$133, 0010$1#0, 0010$151, 001119#5 0009#971, 0010$09$, 0010$099, 0010$100, 0010$101, 0010$116, 0010$099, 0010$200, #05#1301-#05#130# 0002$$53, 00036222, 00036223, 00036231, 000376$$, 0003$770, 0003$979, 000###23, 000519$2, 00053002, 00053005, 0006010$, 00061559, 0006371#, 00065751, 00065752, 00067#25, 00076$05, 0007$$23, 0007$$2#, 0010$133, 0010$1##, 0010$1#9, 0010$151, 0010$175, 0010$176, 0010$1$6, 0010$231, 001119#5, 001119#9, 00122715, 00159#19, 0016#729, #0502601, #05#130# 000391#2, 000#00$3, 000519$0, 00053002, 00061553, 00061555, 0010$129, 0010$132, #0502605, #053200#, #19#0701
6171-# 'b(7 %nimal /e!abolism
6171-# 'c( and 'd(7 -esidue %naly!ical /e!hods
6171-# 'e(7 2!orage 2!abili!y
4uideline"5ommodi!y 6171-# 'k( 'l(7 /agni!ude o !he -esidue in 8lan!s -oo! and 9uber 1ege!ables 4roup - %r!ichokes, :erusalem - ;ee!s, garden - 5arro!s - 5hicory - <orseradish - 8arsnips - 8o!a!oes - -adish - -u!abagas - 2alsi y - 2ugar bee!s - 2wee! po!a!o - 9urnips =eaves o -oo! and 9uber 1ege!ables 4roup - ;ee!s, greens - 5hicory leaves - 2ugar bee! !ops - 9urnip !ops ;ulb 1ege!ables 4roup - 4arlic - &nions 'green and dry bulb( =ea y 1ege!ables 'e>cep! ;rassica( 4roup - 5elery - =e!!uce 'head and lea ( - 2pinach ,"% 0010$159 ,"% ,"% #07$3101 ,"% ,"% 000393$1, 0010$151 #0$35201 ,"% 0010$159 0010$159 ,"% ,"% ,"% 0010$151, #19#7001 0010$159 ,"% ,"% 000393$1, 0010$151 0010$151 #0$35201
-e erences 1
4uideline"5ommodi!y ;rassica =ea y 1ege!ables 4roup - ;roccoli - 5abbage - 5auli lower - ?ale - /us!ard greens =egume 1ege!ables '2ucculen!"+ried( 4roup - ;eans 'succulen! and dried( - =en!ils - 8eas 'succulen! and dried( - 2oybeans 0010$159 0010$159 0010$159 #0$02$01, #0$02$01 0010$159 ,"% ,"% #0$02$01, #0$02$01
-e erences 1
00015759, 00015760, 00015761, 00015762, 00015763, 0001576#, 00015765, 00015766, 00015767, 0002#503, 0003395#, 0003$90$, 000#00$#, 00061555, 0010$153, 0010$203 00061555, 0010$153, 00156793
'processed commodi!ies( @oliage o =egume 1ege!ables '2ucculen!"+ried( 4roup - ;ean vines and hay - =en!il orage and hay - 8ea vines and s!raw - 2oybean orage and hay
0010$159 0010$159 00015759, 00015760, 00015761, 00015762, 00015763, 0001576#, 00015765, 00015766, 00015767, 0003395#, 0003$90$, 000#00$#, 00061555, 0010$153, 0010$203
@rui!ing 1ege!ables 4roup 5ucurbi! 1ege!ables 4roup 5i!rus @rui!s 4roup 'processed commodi!ies( 8ome @rui!s 4roup 2!one @rui!s 4roup 000391#2 #0159#01 0010$129 001119#9
4uideline"5ommodi!y - 8lums ' resh prunes( 001119#9
-e erences 1
2mall @rui!s and ;erries 4roup - ;lackberries - ;lueberries - 5ranberries - 4rapes 'processed commodi!ies( - -aspberries 9ree ,u!s 4roup - %lmond hulls 5ereal 4rains 4roup - ;arley 'processed commodi!ies( - 5orn ' ield and resh( 'processed commodi!ies( - &a!s 'processed commodi!ies( - -ice 'processed commodi!ies( - -ye 'processed commodi!ies( - 2orghum 'processed commodi!ies( - Ahea! 'processed commodi!ies( @orage, @odder, and 2!raw o 5ereal - ;arley orage, hay, and s!raw 4rains 4roup 0003$90$, 000#00$7, 000###22, 0010$203 0003$90$, 000#00$7, 000###22, 0010$203 ,"% 00023336, 00023512, 000376$7, 0003$90$, 000#00$5, 000#$2$#, 0010$203, #0502602 #050260#, #1#7$101 0003$90$, 000#00$7, 000###22, 0010$203 ,"% 0003$90$, 000#00$7, 000###22 ,"% ,"% ,"% 0003$90$, 000#00$7, 000###22, 0010$203, 00109271, #0502601 #0502603 0003$90$, 000#00$6, 000###26, 0010$203, 00122715, #1#$#301 00150$35 001119#5 001119#5 00053002 0003$770, 0010$132 #07$5303
4uideline"5ommodi!y - 5orn orage and odder - &a! orage, hay, and s!raw - -ice s!raw - -ye orage and s!raw - 2orghum orage and odder - Ahea! orage and s!raw 4rass @orage, @odder, and <ay 4roup ,on-grass %nimal @eeds ' orage, odder, s!raw, and hay( 4roup - %l al a seed /iscellaneous 5ommodi!ies - %cerola - %!emoya - %sparagus - %vocados - ;ananas - ;read rui! - 5anis!el - 5arambola - 5herimoya - 5ocoa beans - 5oconu! - 5o ee beans - 5o!!on 'processed commodi!ies( - +a!es - @igs - 4enip - 4uavas - :abo!icaba - :ack rui! 00059050 #01#9#01 #01#9#01 000519$0, 000519$1 0010$1##, #06#2#01 0010$1#9 0010$175 #01#9#01 #01#9#01
-e erences 1 00023336, 00023512, 000376$7, 0003$90$, 000#00$5, 000#$2$#, 0010$203, #0502602 0003$90$, 000#00$7, 000###22, 0010$203 0003$90$, 000#00$7, 000###22 ,"% 0003$90$, 000#00$7, 000###22, 0010$203, 00109271, #0502601 0003$90$, 000#00$6, 000###26, 0010$203, 00122715 00076$05, 0010$1#7 00076$05, 0010$1#7 #05#130#
00060103, 00061553, 0010$176, 0010$153, 0010$203 00061553, 0010$176, 0010$153 #01#9#01
4uideline"5ommodi!y - ?iwi rui! - =i!chi ,u! '=ychee( - =ongan - /amey 2apo!e '/ammee %pple( - /angoes - &kra - &lives 'processed commodi!ies( - 8alm oil - 8apayas - 8assion @rui! - 8eanu!s 'processed commodi!ies( - 8ersimmons - 8ineapple - 8is!achio - 2apodilla - 2apo!e 'black and whi!e( - 2oursop - 2ugar apple - 2ugarcane 'processed commodi!ies( - 9amarind - 9ea - Aa!ercress 6171-# 'h(7 /agni!ude o !he -esidue in 8lan!s -esul!ing rom !he Bse o *rriga!ion Aa!er 6171-# 'C(7 /agni!ude o !he -esidue in /ea!, /ilk, 8oul!ry, and 0ggs 6171-# 'g(7 /agni!ude o !he -esidue in @ish 0010$1#0 0010$16$ #01#9#01 0007$$23, 0007$$2# ,"% 000393$1, #05#1305 #01#9#01 #01#9#01 001##3#1, 0002$$52 001##3#1, 0002$$52 #01#9#01 ,"% 001119#5 00063713 #05$0#01 ,"% 0010$175, #239$#01 0010$175, #239$#01
-e erences 1
0010$115, #0532001-03
00036229, 00076#91, 0015#311, 00155120
4uideline"5ommodi!y 6171-# ' (7 ,a!ure and /agni!ude !he -esidue in +rinking and *rriga!ion Aa!er
-e erences 1 00039377, 000393$1, 00077227, 0007722$, 00077229, 00077230, 00077231, 00077232, 00077233, 0007723#, 00077235, 00077236, 00077237, 0007723$, 00077301, 0010$173,
6171-# 'i(7 /agni!ude o !he -esidue in @ood <andling 0s!ablishmen! 6171-57 -educ!ion o -esidues 1 ,"% means no! available by /-*+ numberD 9hose guidelines"commodi!ies which do no! lis! a /-*+ re erence number, addi!ional re erence in orma!ion can be provided rom 9able % in !he 8roduc! and -esidue 5hemis!ry 5hap!ers by -D;D 8er e!!i, 5hemis!ry ;ranch -eregis!ra!ion 2uppor! '5;-2E 10665( in !he <eal!h 0 ec!s +ivision da!ed 10"27"92 !hrough @&*D
En+ironmental Assessment +. Environmental $ate a. Environmental $ate and Transport =+> Hydrolysis %lyphosate is sta&le at pH 0@ 2@ . at 1 and 01EC. =#ccession //+/5+.,> =,> 'hotodegradation in Cater %lyphosate is sta&le to photodegradation in pH 1@ -@ and . &!ffered sol!tions !nder nat!ral s!nlight. =3RID 6+25.+/+> =0> 'hotodegradation on Soil %lyphosate is sta&le to photodegradation on soil. =3RID 6+001+/+> =6> #ero&ic Soil 3eta&olism
Data indicate half"life val!es of +.51 and ,./2 days in Ric*apoo sandy loam and D!po silt loam respectively. #minomethyl phosphonic acid =#3'#> was the ma(or degradate. =3RID 6,0-,1/+> =1> #naero&ic #:!atic 3eta&olism %lyphosate has a half"life of 5.+ days in anaero&ic =flooded pl!s nitrogen atmosphere> silty clay loam sediment. #3'# was the ma(or degradate. =3RID 6,0-,1/,> =2> #ero&ic #:!atic 3eta&olism %lyphosate has a half"life of - days in flooded silty clay loam sediment that was inc!&ated in the dar* at ,6.2 S /.1C for 0/ days. #3'# was the ma(or degradate. =3RID 6,0-,1/0> =-> 9eaching?#dsorption?Desorption Rd val!es of 2,@ ./@ -/@ ,,@ and +-1 were reported for Dr!mmer silty clay loam@ Ray silt@ Spin*s sandy loam@ 9intonia sandy loam@ and Cattail Swamp sediment respectively. #fter =aged> leaching - soils with ,/D of water@ the recovered radioactivity in the soils was .0"+//A of the applied material. =#ccessions //+/5+.,@ ///-26.0@ //+/5+6/> =5> Terrestrial $ield Dissipation The #gency has received an interim report on a terrestrial field dissipation st!dy in progress &y 3onsanto Company. =3RID 6,2/-1/+> This report contains data from eight different field sites. Some of the data from the individ!al field sites are deficientI however@ the #gency may !se the data from the eight field sites together to satisfy the terrestrial field dissipation +26"+ data re:!irement.
The interim report res!lts from the first +, months of &aregro!nd field dissipation trials from eight sites show that the median half"life =DT1/> for glyphosate applied at maxim!m ann!al !se rates =-..1 l& a.e.?acre@ +/.- l& a.i.?acre> was +0.. days with a range of ,.2 =Texas> to +6/.2 =Iowa> days. #ccepta&le aero&ic soil@ aero&ic a:!atic and anaero&ic a:!atic meta&olism st!dies demonstrate that !nder those conditions at ,1EC in the la&oratory glyphosate degrades rapidly with half"lives of approximately ,@ - and 5 days respectively. The reported half"lives =DT1/> from the field st!dies cond!cted in the coldest climates@ ie. 3innesota@ 4ew Kor* and Iowa@ were the longest at ,5.-@ +,-.5@ and +6/.2 days respectively indicating that glyphosate resid!es in the field are somewhat more persistent in cooler climates as opposed to milder ones =%eorgia@ California@ #ri7ona@ hio@ and Texas>. %lyphosate =as well as #3'#> was shown to remain predominantly in the /"2 inch soil layer thro!gho!t the d!ration of the st!dy at all field sites. Iowa was the individ!al test site to have average glyphosate resid!es@ at all sampling times@ greater than /./+ ppm in the 2"+, inch depth. There were a n!m&er of detections from /./+ to /./. ppm in the 2" +, inch layer in 3innesota@ 4ew Kor* and Texas@ and glyphosate was detected at generally M/./1 ppm at the other 1 field sites =2"+, inch depth>. %lyphosate was detected at three different sites &elow +, inches. In California@ at / D#T@ average glyphosate resid!es were /.,+ ppm and /.+/ ppm in the +,"+5 and +5" ,6 inch soil hori7ons respectively. Soil core contamination was attri&!ted to these detections since movement of resid!es to this depth on the first day of sampling is !nli*ely. In #ri7ona at ,+ D#T the average glyphosate resid!es were /./2@ in the +5",6 inch soil layer. There were no glyphosate resid!es in the 2"+, or +,"+5 inch soil layer in
#ri7ona on ,+ D#T and in s!&se:!ent samples &elow +, inches which may indicate a pro&lem with sampling techni:!e. In Iowa at +./ D#T the average glyphosate resid!es were /./1 ppm in the +,"+5 inch soil layer. Since there were no glyphosate resid!es detected in the 2"+, inch soil layer at +./ D#T@ and
the lac* of a significant amo!nt of rainfall &etween sampling intervals in com&ination with the amo!nt of time &etween sampling intervals and the high adsorptive characteristics of glyphosate give an indication that there may have &een a pro&lem with sampling techni:!e. #3'# was also shown to remain predominantly in the /"2 inch soil layer. #3'# was fo!nd at every test site on Day / samples indicating the rapid degradation of parent glyphosate. The #3'# levels generally reached a maxim!m &etween day +6 and day 0/. Chere the field half"lives were longer =Iowa@ 3innesota@ 4ew Kor*>@ the maxim!m average #3'# levels occ!rred &etween 2, and .1 D#T. The maxim!m average #3'# levels fo!nd in the /"2 inch soil layer were /.2 ppm and occ!rred in hio and %eorgia at ,+ D#T and 2+ D#T respectively. The #3'# levels at those sites had decreased to /.+, and /.66 ppm at +, months after treatment. In all samples &!t three@ #3'# resid!e levels were M/./1 ppm in the 2"+, inch soil layer. In 4ew Kor* at +6 and 0/ D#T average resid!es were detected at /./2 ppm. In Iowa at the ., D#T sample average #3'# resid!es were /./5 ppm. Iowa and 4ew Kor* also exhi&ited 1/A dissipation times of +6/.2 and +,-.5 days respectively. #3'# levels were detected at /./2 ppm in the +5" ,6 inch soil layer on ,+ D#T in #ri7ona and /./6 and /./0 ppm in the +,"+5 inch soil layer at ./ and +5/ D#T respectively in 4ew Kor*. # final report on the terrestrial field dissipation st!dy showed the median half"life =DT1/ > =of eight sites> of #3'# was ,6/ days with a range of ++. = hio> to .15 =California> days. The half"lives for the dissipation of #3'# for seven of the eight test sites wereB ; #ri7ona +6, days
; ; ;
California %eorgia 3innesota
.15 days 5.2 days 0/, days
; ; ;
4ew Kor* ,6/ days hio ++. days Texas +0+ days
Iowa was not calc!lated &eca!se recharging of #3'# resid!es was greater than degradation. #3'# was shown to remain predominantly in the /"2 inch soil layer thro!gho!t the d!ration of the st!dy at all eight field sites. #3'# was detected three times =at a concentration greater than /./1 ppm> at depths greater than +, inches. The three detections were attri&!ted to contamination d!ring sampling rather than vertical mo&ility. =.> #:!atic $ield Dissipation %lyphosate dissipated from water =irrigation so!rce> with a calc!lated half"life of -.1 days and +,/ days from the sediment of the farm pond in 3isso!ri. =3RID 6/55+2/+> In 3ichigan@ %eorgia and regon pond and stream water@ the maxim!m glyphosate concentrations were meas!red immediately posttreatment and dissipated rapidly. %lyphosate acc!m!lated in the pond sediment@ and to a lesser extent in the stream sedimentsI glyphosate was present in pond sediment at $+ ppm in 3ichigan and regon at approximately + year posttreatment. =3RID 6+11,5/+> =+/> $orestry Dissipation Chen aerially applied at 0.-1 l&?# to forested sites in 3ichigan@ regon@ and %eorgia@ glyphosate averaged 21," +,-0 ppm in tree foliage immediately posttreatment. It then declined rapidly with half"lives of M+ day at the 3ichigan and %eorgia sites and M+6 days at the regon site. The forestry dissipation st!dy res!lts demonstrate that when !sed !nder normal silvic!lt!re practices according to la&el directions@ the maxim!m com&ined
glyphosate and #3'# resid!e level in soil is less than 1 ppm. %lyphosate and #3'# resid!es in soil dissipate with time. The average half"life for the dissipation of glyphosate was +// days@ and
ranged from 01 to +15 days. The average half"life for the dissipation of #3'# was ++5 days@ and ranged from -+ days to +21 days. =3RID 6+11,5/+> =++> #cc!m!lation in Confined Rotational Crops %lyphosate resid!es =expressed as fresh weight> acc!m!lated in lett!ce@ carrots@ and &arley planted 0/@ ++.@ and 026 days after sandy loam soil was treated with glyphosate at 0.-+ l& ai?#. #cc!m!lation decreased as the length of the rotation increased. In crops planted at 0/ days@ posttreatment@ O+6 CPresid!es at harvest were /./.ppm in lett!ce@ /./1+ and /./0- ppm in carrot tops and roots@ respectively@ and /.+55 and /.+-1 ppm in &arley grain and straw@ respectively. In immat!re lett!ce harvested at 6/ and 2/ days postplanting@ O+6 CPresid!es were /.+/5 and /./65 ppm@ respectively. In crops planted at ++. days posttreatment@ O+6 CPresid!es at harvest were /./0- ppm in lett!ce@ /./,5 and /./+- ppm in carrot tops and roots@ respectively@ and /./-5 and /./12 ppm in &arley grain and straw@ respectively. In immat!re lett!ce harvested at ,5 and 65 days postplanting@ O+6CPresid!es were /./1. and /./11 ppm@ respectively. In crops planted at 026 days posttreatment@ O+6CPresid!es at harvest were /./,5 ppm in lett!ce@ /./+5 and /.//.2 ppm in carrot tops and roots@ respectively@ and /./6- and /./2+ ppm in &arley grain and straw@ respectively. In immat!re lett!ce harvested at 01 and 2+ days postplanting@ O+6 CPresid!es were /./1- and /./60 ppm@ respectivelyI in &arley forage harvested at 65 days postplanting@ O+6 CPresid!es were /./12 ppm. =3RID 6+160,/+ and 6+160,/,> =+,> #cc!m!lation in Irrigated Crops #lfalfa@ corn =grain and forage>@ grass =fesc!e or s!dan> and lett!ce were irrigated five to eight times d!ring the +.5- growing season with glyphosate treated water
containing a maxim!m of ,+.0 ppm =on treatment day then fell to /.62 ppm &y + day after treatment> of glyphosate. Resid!es in the sediment &eneath the treated water reached a maxim!m of 0.1 ppm at +6 days after treatment. Resid!es
of glyphosate in the sprin*ler water at the pond site were the highest - days after treatment at /.+, ppm. ne lett!ce sample from the 3isso!ri location =the pond site> at ,. days after treatment =of water so!rce> and 1 irrigation events was fo!nd to contain /./2 ppm glyphosate. =3RID 6/16+0/1> =+0> Bioacc!m!lation in $ish 3axim!m &ioconcentration factors were /.05T for edi&le tiss!es@ /.20T for nonedi&le tiss!es@ and /.1,T for whole fish. =3RID 6+,,50/+>
=+6>
9a&oratory and $ield Holatility The re:!irement of these st!dies was waived &ased on the low vapor press!re of glyphosate.
&.
Environmental $ate and %ro!ndwater #ssessment In general@ the availa&le field and la&oratory data indicate glyphosate adsor&s strongly to soil and wo!ld not &e expected to move vertically &elow the 2 inch soil layer. Based on !naged &atch e:!ili&ri!m st!dies glyphosate and glyphosate resid!es are expected to &e immo&ile with Rd=ads> val!es ranging from 2, to +-1. The mechanism of adsorption is !nclearI however@ it is spec!lated that it may &e associated with vacant phosphate sorption sites or high levels of metallic soil cations. The data indicate that chemical and photochemical decomposition is not a significant pathway of degradation of glyphosate in soil and water. However@ glyphosate is readily degraded &y soil micro&es to aminomethyl phosphonic acid =#3'#>@ which is degraded to C ,@ altho!gh at a slower rate than parent glyphosate. Even tho!gh glyphosate is highly water sol!&le it appears that parent glyphosate and #3'# have a low potential to move to gro!nd" water d!e to their strong adsorptive characteristics demonstrated in the la&oratory and field st!dies. However@ glyphosate does have the potential to contaminate s!rface waters d!e to its a:!atic !se patterns and erosion via transport of resid!es adsor&ed to soil particles s!spended in r!noff water. If glyphosate were to reach s!rface water it wo!ld &e resistant to hydrolysis and a:!eo!s photolysis. Based on the low vapor press!re of glyphosate@ volatili7ation from soils will not &e an important dissipation mechanism. The low octanol?water coefficient s!ggests that glyphosate will have a low tendency to acc!m!late in fish.
,.
Ecological Effects a. Ecological Ha7ard
=+>
Effects to 4ontarget Birds To esta&lish the toxicity of glyphosate to &irds@ tests were re:!ired !sing the technical grade material. =a> #vian Single"Dose ral 9D1/ " Technical
Acute Oral Toxicity ,indings

Species ;obwhi!e .uail - AI $3F .%0 (#%- + ) ) 2000 mg"kg +onclusions prac!ically non-!o>ic !o upland game birds
One a/ian single&dose oral study on either a 0ater1o0l species (pre1era2ly 3allard duc4) or an upland species (pre1era2ly 2o20hite 5uail) 0as re5uired6 These data indicate that technical glyphosate is practically non&toxic to an upland 2ird species on an acute oral 2asis6 The guideline re5uire3ent 1or an a/ian acute oral study is 1ul1illed6 (Study I. !')'#%)
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#vian Dietary " Technical
A/ian Su2acute .ietary Toxicity ,indings

Species - AI *eproducti/e I3pair3ent ) #6#0 ppm ) #6#0 ppm +onclusions
/allard duck ;obwhi!e .uail
9$D5F 9ech 9$DF 9ech
no more !han sligh!ly !o>ic !o upland game birds and wa!er owl
T0o su2acute dietary studies" one study on a species o1 0ater1o0l (pre1era2ly 3allard duc4) and one on an upland ga3e 2ird species (pre1era2ly a 2o20hite 5uail)" 0ere re5uired6 These data indicate that the technical glyphosate is no 3ore than slightly toxic to 2irds on a dietary 2asis6 The guideline re5uire3ent is 1ul1illed 1or 2oth studies6 (Study I.s #)1(1 and 000$7)#!)
=c>
#vian Reprod!ction
A/ian *eproduction ,indings

Species - AI *eproducti/e I3pair3ent ,o e ec!s up !o 1000 ppm ,o e ec!s up !o 30 ppm ,o e ec!s up !o 1000 ppm +onclusions
/allard duck /allard duck ;obwhi!e .uail
$3F 9ech 90D#F 9ech $3F 9ech
no! e>pec!ed !o cause reproduc!ive impairmen!
An a/ian reproduction test 0as re5uired to support registration o1 the end&use products o1 glyphosate since the 1ollo0ing guideline criteria ha/e 2een exceeded6 The la2eling 1or se/eral use patterns contains directions 1or use under 0hich 2irds 3ay 2e su28ect to repeated exposure to glyphosate6 The la2eling allo0s repeat application 1or certain uses" such as al1al1a" 2arley" oats" apples" cherries" and oranges6 These data indicate that technical glyphosate is not expected to cause reproducti/e i3pair3ent6 The guideline re5uire3ents 1or an a/ian reproduction study on 2oth upland ga3e 2ird and 0ater1o0l are 1ul1illed6 (Study I.s !'%#!)" 000'7'!$" and !'%#!))
=d>
S!mmary of $indings %lyphosate is practically non"toxic to &o&white :!ail on the &asis of ac!te oral toxicity. #n 9D1/ greater than ,/// mg?*g was determined for &o&white :!ail given a single oral dose of technical glyphosate. St!dies indicate that the 5" day dietary 9C1/ of the chemical is greater than 6/// ppm for &oth mallard d!c*s and &o&white :!ail. These data indicate that the chemical is slightly toxic to &irds. #vian reprod!ction st!dies indicate reprod!ctive impairment wo!ld not &e expected at a dietary level of !p to +/// ppm. The availa&le ac!te toxicity data do not indicate a re:!irement of preca!tionary la&eling for &irds on prod!cts containing glyphosate.
=,>
Effects on 4on"Target $ish =a> #c!te Toxicity to $reshwater $ish
Acute Toxicity to ,resh0ater ,ish ,indings

Species - AI )$&hr +%0 (#%-+ ) ) 2# mg"l $#D9 mg"l '72D9-99D3( 120 mg"l '111130( $6 mg"l '70106( 1#0 mg"l '120170( 97 mg"l '79120( 130 mg"l '110160( 1#0 mg"l '110160( +onclusions
;luegill sun ish @a!head /innow ;luegill sun ish -ainbow 9rou! -ainbow 9rou! @a!head minnow 5hannel ca! ish ;luegill sun ish
96D5F $7D3F $3F $3F 96D7F 96D7F 96D7F 96D7F
ranges in !o>ici!y rom sligh!ly non-!o>ic !o prac!ically non-!o>ic !o bo!h cold wa!er and warm wa!er ish
The 3ini3u3 data re5uired 1or esta2lishing the acute toxicity o1 glyphosate to 1resh0ater 1ish are the results o1 t0o #7&hour studies 0ith the technical grade product6 One study 0as to 2e per1or3ed on a cold 0ater 1ish species (pre1era2ly rain2o0 trout) and one study 0as to 2e per1or3ed using a 0ar3 0ater species (pre1era2ly 2luegill sun1ish)6 The results o1 these eight studies indicate that technical glyphosate is slightly to practically nontoxic to 2oth cold 0ater and 0ar3 0ater 1ish6 The guidelines re5uire3ent 1or acute toxicity testing o1 the technical on 1resh0ater 1ish is 1ul1illed6 (Study I.s 0010$11!" 0010$1(1" !')'#%" 0#(771" and !)#170)
=&>
Chronic Toxicity to $reshwater $ish
+hronic Toxicity to ,resh0ater ,ish ,indings

Species @a!head /innow - AI $7D3F !ech *esults /%95 ) 25D7 mg"l +onclusions no e ec!s a! or below !his level
.ue to the a5uatic use o1 the che3ical" its presence in 0ater is li4ely to 2e continuous or recurrent regardless o1 toxicity9 there1ore" chronic testing 0as re5uired6 This 1ish 1ull li1e cycle study satis1ies the generic guideline re5uire3ent 1or chronic 1resh0ater 1ish testing6 (Study I. 0010$1(1)
Acute Toxicity to ,resh0ater ,ish ,indings 1ro3 Studies using ,or3ulated Products
Species - AI (IPA salt) #1D$F #1D$F #1D36F #1D36 #1D36F #1D36F 62D#F 62D#F G#1D2F H 15D3 I%%I sur ac!an! #7&hr +%0 (#%- + ) 5D$ mg"l '#D#-$D3( $D2 mg"l '6D#-9D0( 16 mg"l '9D#-26( 11 mg"l '$D7-1#( 1# mg"l '$D7-2#( 9D# mg"l '5D6-16( )1000 mg"l )1000 mg"l 120 mg"l '56-1$0( +onclusions
;luegill sun ish -ainbow 9rou! 5hannel ca! ish -ainbow 9rou! ;luegill sun ish @a!head /innow -ainbow 9rou! ;luegill sun ish -ainbow 9rou!
ranges in !o>ici!y rom modera!ely !o>ic !o prac!ically non!o>ic !o bo!h warmwa!er and coldwa!er ish
Acute Toxicity to ,resh0ater ,ish ,indings 1ro3 Studies using ,or3ulated Products
-ainbow 9rou! ;luegill sun ish ;luegill sun ish G#0D7F H 15F IAI sur ac!an! G#0D7F H 15F IAI sur ac!an! G#1D2F H 15D3F I%%I sur ac!an! 7D03F H 0D5F IJ77I 7D03FH 0D5F IJ77I 150 mg"l '100320( )100 mg"l
)1$0 mg"l
-ainbow 9rou! ;luegill sun ish
2#0 mg"l '1$0-320 mg"l( $30 mg"l '6201600(
-ainbow 9rou! @a!head minnows -ainbow 9rou! ;luegill sun ish 5hannel ca! ish ;luegill sun ish -ainbow 9rou!
51F #1F #1F #1F #1F #1F #1F
$D3 mg"l '7D0-9D9( 2D3 mg"l '1D9-2D$( 9D0 mg"l '7D5-11( #D3 mg"l '3D#-5D5( 13 mg"l '11-16( 5 mg"l '3D$-6D6( 1D3 mg"l '1D1-16(
Testing o1 an end&use product is re5uired i1 the pesticide 0ill 2e introduced directly into an a5uatic en/iron3ent 0hen used as directed 2y the la2el6 .rainage syste3s 0ould 2e included in such a category6 There1ore" 1or3ulated product testing 0as re5uired6 According to the sur1actant selected" the 1or3ulated product toxicity ranges 1ro3 3oderately toxic to practically non&toxic6 (Study I. !)#1%#" 000(0$#)"
000(0$#%" 000(0$#(" 000(0$#7" 000($771" 000($77!" 000($7%$" 000($7%%" 000($7%7" 000($7%#" 000($77)" 000($77%" !)#170)
Sur1actant Test ,indings

Species - AI #7&hour +%0 (#%- + ) 1D0 mg"l '1D21D7( 2D0 mg"l '1D52D7( 0D65 mg"l 'D5#D7$( 13 mg"l '10-17( 3D0 '2D5-3D7( 1 mg"l 'D72-1D#( +onclusions
@a!head minnow -ainbow !rou! -ainbow 9rou! 5hannel 5a! ish ;luegill sun ish ;luegill sun ish
/&,&$1$ 9ech 100F /&,&$1$ 9ech 100F /&,&$1$ /&,&$l$ 9ech 100F /&,&$l$ 9ech 100F /&,&$1$ 9ech 100F
ranges in !o>ici!y rom highly !o>ic !o sligh!ly !o>ic !o warmwa!er and coldwa!er ish
Testing o1 the sur1actant 3ay 2e re5uired under unusual circu3stances6 :hen inerts are li4ely to 2e toxic" testing can 2e re5uired6 These data indicate that MO;O$1$ ranges 1ro3 3oderately toxic to /ery highly toxic to 2oth cold and 0ar3 0ater 1ish a1ter #7 hour exposure6 (Study I. !)#170)
=c>
S!mmary of $indings Three tests on warm water species@ one &l!egill and two with fathead minnow@ prod!ced the .2"ho!r 9C1/s of +,/ ppm@ 56.. ppm@ and .- ppm@ respectively =3c#llister and $or&is +.-5@ ID F,060.1I E% ) % Bionomics +.-1@ ID F//+/5+-+ and $olmar@ Sanders@ and E!lin +.-.@ ID F,6.+2/>. Two rain&ow tro!t .2"ho!r 9C1/s provided val!es of 52 ppm and +6/ ppm. Based on these tests@ technical glyphosate ranges from slightly to practically non"toxic to freshwater fish species. S!rfactant testing was performed with &oth cold water and warm water fish. In this case@ the
initial form!lation demonstrated an application rate m!ch
lower than technical glyphosate. The 9C1/ for rain&ow tro!t was +.0 mg?l or moderately toxic. The s!rfactant =3 4/5+5> when tested alone prod!ced an 9C1 / val!e of /.21 mg?l for rain&ow tro!t indicating a highly toxic category =$olmar et al. +.-.@ ID F,6.+2/>. In contrast@ the form!lation of 6+., percent isopropylamine salt and +1.0 percent D##D s!rfactant provided a rain&ow tro!t 9C1/ of +,/ mg?l@ indicating a practically non"toxic compo!nd =Thompson and %riffen +.5/@ ID F///-5215>. Bl!egill are in the same category of toxicity with an even higher 9C1/ of greater than +5/ mg?l =Thompson and %riffen +.5/@ ID F///-521.>. The &l!egill and rain&ow tro!t were similar in sensitivity to the form!lation containing the DCD s!rfactant with 9C1/ val!es of +1/ and Q+// mg?l@ respectively. #lso@ neither rain&ow tro!t =9C1/ ,6/ mg?l> nor &l!egill =9C1/ 50/ mg?l> were very sensitive to the x"--=.1> s!rfactant and glyphosate=-./0A>. The s!rfactant 3 4/5+5 has &een tested separately@ prod!cing an 9C1/ of +0 mg?l on hironomous indicating it is a slightly toxic material. $or fish@ the catfish appears to &e the most tolerant with an 9C1/ val!e of +0 mg?l@ and rain&ow tro!t the most sensitive with an 9C1/ val!e of /.21 mg?l. Based !pon availa&le data prod!cts containing 3 4 5l5 m!st incl!de the statement@ DThis pesticide is toxic to fish.D
=0>
Effects on #:!atic Inverte&rates =a> #c!te Toxicity to $reshwater Inverte&rates
Acute Toxicity to ,resh0ater In/erte2rates ,indings

Species Daphnia magna Chironomus plumosus - AI $3F !ech 96D7F !ech )$&hr +%0 (pp3) 7$0 55 '31-97( +onclusions ranges in !o>ici!y rom sligh!ly !o>ic !o prac!ically non-!o>ic !o reshwa!er inver!ebra!es
The 3ini3u3 data re5uire3ent to esta2lish the acute toxicity o1 glyphosate to 1resh0ater in/erte2rates is a )$&hour acute study using the technical 3aterial6 Test organis3s should 2e 1irst instar Daphnia magna or early instar a3phipods" stone 1lies or 3ay1lies6 The results o1 these studies indicate that technical glyphosate is slightly toxic to Chironomus plumosus and is practically non toxic to Daphnia magna 6 The guideline re5uire3ent 1or acute testing on a 1resh0ater in/erte2rate has 2een 1ul1illed6 (Study I. 0010$1(!" and !)#170)
=&>
Chronic Toxicity to $reshwater Inverte&rates
+hronic Toxicity to ,resh0ater In/erte2rates ,indings

Species Daphnia magna - AI 99D7F !ech
Acute *esults Toxicity to ,resh0ater In/erte2rates +onclusions ,indings 1ro3 Studies using ,or3ulated Products
/%95 ) 50 -K 96 mg"= caused reduced reproduc!ive capaci!y
.ue to the a5uatic use o1 the che3ical its presence in 0ater is li4ely to 2e continuous or recurrent regardless o1 toxicity9 there1ore" chronic testing 0as re5uired6 This study satis1ies the guideline Species re5uire3ent 1or chronic 1resh0ater in/erte2rate testing6 (Study I. !)#170) - AI (IPA salt) )$&hr +%0 (pp3) +onclusions
Daphnia magna 62D#F $69 '7031019(
!o reshwa!er inver!ebra!es
ranges in !o>ici!y rom modera!ely !o>ic !o prac!ically non-!o>ic
Acute Toxicity to ,resh0ater In/erte2rates ,indings 1ro3 Studies using ,or3ulated Products
Daphnia magna
#1D2F H I%%I sur ac!an! L 15D3F #0D7F /&,2139 H 15F IAI sur ac!an! #1F #1F #1F 51F /&, 2139 #1D36F #1D$3F
310 '250#00(
Daphnia magna
72 '62-$3(
Daphnia magna Gammarus pseudolimnaeus Chironomus plumosus Daphnia pulex Daphnia magna Gammarus pseudolimnaeus
3 '2D6-3D#( 62 '#0-9$( 1$ '9D#-32( 2#2'22#261D5( 5D3 '#D#-6D3( #1D9 '30D762( Other results
Ephemerella walkeri
#1F
/ay ly nymphs avoided glyphosa!e a! concen!ra!io ns o 10 mg"= bu! no! a! 1D0 mg"lD
Acute Toxicity to ,resh0ater In/erte2rates ,indings 1ro3 Studies using ,or3ulated Products
Chironomus plumosus #1F 2igni ican! increases in s!ream dri ! o midge larvae was observed a !er !he 2D0 mg"l, bu! no! a! !he 0D02 or 0D2 mg"l levelD
Testing o1 an end&use product is re5uired i1 the pesticide 0ill 2e introduced directly into an a5uatic en/iron3ent 0hen used as directed 2y the la2el6 .rainage syste3s (0et and dry) 0ould 2e included in such a category6 There1ore" 1or3ulated product testing 0as re5uired6 According to the sur1actant selected" the 1or3ulated product toxicity ranges 1ro3 3oderately toxic to practically non&toxic6 (Study I. 000($77'" 000($777" 000($770" 000($7%(" !)#170" 0010$10#" 000(0$#'" and !)#1%#)
Sur1actant Test ,indings

Species - AI )$&hr +%0 (#%-+ ) 13 mg"= '7D1-2#( +onclusions
Daphnia magna
100F /&,&$1$ sur ac!an!
sligh!ly !o>ic !o reshwa!er inver!ebra!es
Testing o1 the sur1actant 3ay 2e re5uired under unusual circu3stances6 One test on the sur1actant 0as recei/ed and deter3ined as accepta2le 1or use in a ris4 assess3ent6 (Study I. !)#170)
=d>
S!mmary of $indings # 65"ho!r 9C1/ of -5/ ppm =mg?l> was fo!nd for #aphnia ma&na exposed to technical glyphosate =3c#llister and $or&is +.-5@ ID F//+/5+-,>. The res!lts of this st!dy indicate that the chemical is practically non"toxic to a:!atic inverte&rates. In addition to these ac!te st!dies@ a fish life" cycle st!dy indicates technical glyphosate has a
3#TC greater than ,1.- ppm. 4o effect was o&served at the highest level tested. # #aphnia ma&na life cycle st!dy with an 3#TC of Q1/ " M.2 ppm reported red!ced reprod!ctive capacity@ the most sensitive parameter. The availa&le ac!te toxicity data indicate that preca!tionary la&eling for freshwater interverte&rates is not re:!ired for prod!cts containing glyphosate. In order to determine the effect of the three s!rfactants =DCD@ D##D@ and DT"--D> on inverte&rates@ additional #aphnia st!dies were cond!cted. The -./0 percent isopropylamine salt of glyphosate with a s!rfactant at /.1 percent identified as T"-- res!lted in an 9C1/ of greater than +/// mg?l or practically non" toxic category for #aphnia. The second com&ination was 6+., percent isopropylamine and +1.0 percent of a s!rfactant identified as D##.D This 9C1/ was 0+/ ppm which wo!ld indicate it is practically non"toxic to #aphnia. The third com&ination consisted of 6/.- percent isopropylamine and +1 percent of a s!rfactant identified as DC.D The res!ltant 9C1/ of -, ppm reveals that this material is slightly toxic to #aphnia. # glyphosate form!lation was tested several times with different inverte&rates. The 9C1/ val!es ranged from 0 mg?l for #aphnia to 2, mg?l for Gammarus indicating a moderately toxic material for #aphnia and no more than slightly toxic for Gammarus. =6> Effects on 3arine?Est!arine rganisms
=a>
#c!te Toxicity #c!te toxicity testing for est!arine and marine organisms on technical glyphosate is re:!ired. The g!idelines re:!ire est!arine and marine st!dies when expos!re of s!ch waters is li*ely. Crops@ s!ch as cotton@ corn@ s!garcane@ t!rf@ citr!s@ &erries@ forestry@ sorgh!m@ watermelon@ etc. wo!ld allow this type of expos!re to occ!r. #c!te toxicity testing for est!arine and marine organisms on form!lated glyphosate may &e re:!ired when expos!re to est!arine and marine water is expected. The !se in drainage systems =wet or dry> wo!ld allow this type of expos!re. 3inim!m re:!irements are res!lts from testing the technical on one est!arine fish =.2 hrs 9C1/ > and either a 65 hrs oyster larvae st!dy or a .2 hrs shell deposition st!dy. #gain@ since there is s!ch an extensive data set for this chemical@ the #gency can determine that glyphosate demonstrates low toxicity to fish and oyster species@ and therefore is waiving the marine fish and oyster ac!te toxicity st!dies on the form!lated prod!ct.
Acute Toxicity to <stuarine and Marine Organis3s ,indings

Species 4rass shrimp @iddler crab %!lan!ic oys!er - AI 96D7F !ech 96D7F !ech 96D7F !ech *esults =550 2$1 ppm '207-3$1( =550 93# ppm '555-1570( 9=50 ) 10 mg"= or #$ hours +onclusions ranges in !o>ici!y rom sligh!ly !o prac!ically non-!o>ic !o marine organisms
These data on 3arine=estuarine species are accepta2le 1or use in a ris4 assess3ent6 These data indicate that technical glyphosate is practically non&toxic to grass shri3p" 1iddler cra2" and slightly toxic to the Atlantic oyster6 Acute toxicity testing on an estuarine 1ish species is nor3ally re5uired6 >o0e/er" since there is such an extensi/e data set 1or this che3ical" the Agency can deter3ine that glyphosate
de3onstrates lo0 toxicity to 1ish species" and there1ore is 0ai/ing the 3arine 1ish acute toxicity study6 (Study I. 0010$110" and 0010$111)
=&>
S!mmary of $indings # series of st!dies were performed on marine? est!arine species. # .2"ho!r 9C1/ of ,5+ ppm was determined for grass shrimp =Palaemonetas vul&aris>. In a st!dy on fiddler cra&s =%ca pu&ilator>@ it was determined that the .2"ho!r 9C1/ is .06 ppm glyphosate. Both of these st!dies indicate technical glyphosate is practically non"toxic to grass shrimp and fiddler cra&s. #n em&ryo"larvae 65"ho!r T9 1/ for #tlantic oyster greater than +/ ppm indicating glyphosate is slightly toxic.
=1>
Effects on 4on"Target Insects =a> #c!te Toxicity Testing
Acute Toxicity to >oney2ees .ata

Species <oneybee acu!e oral <oneybee acu!e oral <oneybee acu!e con!ac! <oneybee acu!e con!ac! AI !echG5867573 36 F /&,2139 !echG5867573 36 F /&,2139 *esults oral =+ 50 ) 100Mg"bee oral =+ 50 ) 100Mg"bee con!ac! =+ 50 ) 100Mg"bee con!ac! =+ 50 ) 100Mg"bee +onclusions prac!ically non-!o>ic !o honeybees on an acu!e oral and acu!e con!ac! basis
G - 9he percen!age o ac!ive ingredien! used was no! repor!edD
The guidelines re5uire acute toxicity testing to honey2ees on the technical 0hen a her2icide is registered as a general use her2icide6 Gi/en the 3ultitude o1 use patterns 1or 0hich this che3ical is registered" acute honey2ee toxicity studies are re5uired6 ?ased on these data" glyphosate (+P7(%(') is considered practically nontoxic on the 2asis o1 acute contact toxicity" as 0ell as on acute oral toxicity6 These data satis1y guideline re5uire3ents 1or nontarget insect studies 0hen glyphosate is used as a general use her2icide6 (,iche ;o6 000!7)$#)
=&>
S!mmary of $indings $o!r st!dies were cond!cted@ two on technical glyphosate and two on the form!lation 3 4,+0.@ consisting of 02 A active ingredient. Res!lts from the honey&ee ac!te oral toxicity st!dy indicates &oth technical and form!lated glyphosate are practically nontoxic to the honey &ee with 9D1/ val!es greater than +// Ug?&ee. Res!lts from the honey&ee ac!te contact toxicity st!dy indicates &oth technical and form!lated glyphosate are practically nontoxic to the honey &ee with 9D1/ val!es greater than +// Ug?&ee.
=2>
Effects to 4on"Target 'lants Chen a her&icide is applied as a terrestrial nonfood !se@ a:!atic nonfood !se@ or as a forestry !se@ Tier I nontarget phytotoxicity st!dies are re:!ired in order to eval!ate the effects of the her&icide on nontarget plants. =a> 'hytotoxicity Testing
<11ects on ;on&Target Plant ,indings

Species Selenastrum capricornutum Navicula pelliculosa Skeletonema costatum nabaena !los" a#uae $emna gibba -AI 96D6 96D6 96D6 96D6 *esults # day 0550 N 12D5 mg"l # +ay 0550 N 39D9 mg"l # day 0550 N 0D$5 mg"l # day 0550 N 11D7 mg"l 7 day 0550 N 21D5 mg"l
96D6
?ased on the results o1 the preceding studies" the data indicates that the ) day <+ %0 ranged 1ro3 06$% 3g=l to '#6# 3g=l 1or 1our a5uatic plant species" and a ( day <+ %0 o1 !16% 3g=l 1or one a5uatic species6
GLYPHOSATE RED September 1993 ?ased
on the data su23itted" the re5uire3ents 1or Tier I and Tier II A5uatic Plant Gro0th Studies (1!!&! and 1!'&!) ha/e 2een 1ul1illed6 A seed ger3ination=seedling e3ergence study 0as conducted (M*I. )01%#'01) on isopropyla3ine salt o1 glyphosate +P&(01'# (Tech) %0- acid 2asis6 The results indicate that +P&(01'# applied at a rate up to 1060 l2 ai=A resulted in @!% - e11ect on the spectru3 o1 3onocots and dicots tested6 ?ased on the results o1 this study" Tier I data re5uire3ents 1or seed ger3ination=seedling e3ergence guideline re1erence 1!!&1 ha/e 2een satis1ied6 (M*I.s )0!'7#01" )0!'7#0!" )0!'7#0'" )0!'7#')" and )0!'7#0%)
=&>
S!mmary of $indings Based on the res!lts of the a:!atic plant growth st!dies which were cond!cted on 1 species@ the data indicates that the 6 day EC1/ ranged from /.51 mg?l to 0... mg?l for fo!r a:!atic plant species@ and a - day EC1/ of ,+.1 mg?l for one a:!atic species. # seed germination?seedling emergence st!dy was cond!cted on isopropylamine salt of glyphosate C'"-/+0. =Tech> 1/A acid &asis. The res!lts indicate that C'"-/+0. applied at a rate !p to +/./ l& ai?# res!lted in M,1 A effect on the spectr!m of monocots and dicots tested. Based on the !se patterns@ the method of application@ and the chemical properties of glyphosate@ additional st!dies are re:!ired to eval!ate the effects on nontarget plants. The recommended la&els do not precl!de off"target movement of glyphosate &y drift. 4or do they address the potential off"target movement via terrestrial plants as well as a:!atic plants. Therefore@ the #gency is re:!iring terrestrial plant test data to assess potential ris* to nontarget plants. The data re:!ired are the Tier II Hegetative Higor %!ideline Reference 4o. +,0" +. In addition@ droplet si7e spectr!m =,/+"+> and drift field eval!ation =,/,"+> data are re:!ired. These three g!ideline st!dies@ Hegetative Higor@ Droplet Si7e Spectr!m@ and Drift $ield
Eval!ation are not considered part of the target data &ase for reregistration. These data do not affect the
reregistration eligi&ility of glyphosate. If@ !pon review of the data from these st!dies@ modification in !se practices and?or preca!tionary meas!res are necessary@ the #gency will re:!ire all registrants to ma*e la&el changes as appropriate. &. Ecological Effects Ris* #ssessment Based on the c!rrent data@ it has &een determined that effects to &irds@ mammals@ fish and inverte&rates are minimal. 8nder certain !se conditions@ glyphosate is expected to ca!se adverse effects to nontarget a:!atic plants. #dditional data are needed in order to f!lly eval!ate the effects of glyphosate on nontarget terrestrial plants. This incl!des res!lts from vegetative vigor testing =+,0"+>@ droplet si7e spectr!m =,/+"+>. In addition@ the drift field eval!ation =,/,"+> st!dy m!st &e s!&mitted and reviewed. Ris* red!ction meas!res cannot &e recommended !ntil data are s!&mitted and eval!ated. =+> 4on"Endangered Species =a> Terrestrial Species The ac!te oral 9D1/ fo!nd for &o&white :!ail dosed with technical glyphosate is greater than 051+ mg?*g. This indicates that the chemical is practically non"toxic to an !pland game species. n a dietary &asis@ the availa&le data indicate that@ at most@ technical glyphosate is slightly toxic to &oth mallards and &o&white =9C1/ Q 626/>. The articles of Hoerger and Renaga =+.-,> and Renaga =+.-0> were cons!lted in order to estimate the maxim!m concentration of glyphosate which may occ!r at the highest application rate for s!ch sites as@ cotton and corn. The following chart addresses the ma(or vegetation categories !pon which fa!na are expected to feed. ,eed +ategory +oncentrations (pp3) A %607!% l2s ai=A
2hor! grass 1215
=ong grass =ea y crops @orageO small insec!s 8odsO large insec!s @rui!
557 632 29# 61 35
Comparing these resid!es to the dietary data for &oth &o&white and mallards =9C1/ Q 626/I +?1th the 9C1/ Q .,5>@ higher !se rates may prod!ce potentially toxic resid!es on short grass only =ass!ming the 9C1/ is (!st over Q 626/>. Cildlife ingesting significant amo!nts of insects@ pods and?or fr!its sho!ld not &e affected &y single applications. Directions for some of the !se patterns do indicate that applications can &e repeated. 3!ltiple treatments co!ld potentially increase resid!es on dietary items within an extended time period. #lso@ the availa&le information s!ggest that glyphosate is relatively persistent. The half"life in soil is as high as ./., days. However@ avian reprod!ction st!dies demonstrated no adverse effects at the highest level tested@ +/// parts per million. Similarly@ ./"day dietary st!dies with dogs and rats indicate no significant a&normalities when the maxim!m level tested is ,/// parts per million. Based on this@ minimal ris* is expected.
=&>
#:!atic Species #:!atic organisms do not appear to &e sensitive to technical glyphosate. The most sensitive a:!atic inverte&rate tested is hironomus plumosus with a 65"hr 9C1/ of 11 ppm which is very near to the lower limit of the #aphnia chronic 3#TC of 1/ mg?l. The most sensitive fish species are fathead minnow and rain&ow tro!t which have .2"ho!r 9C1/ s of 56.. and 52 mg?l. Chronic testing for the technical with fathead minnow provided an 3#TC of Q ,1.- mg?l. Based on the toxicity and the vario!s EEC<s the #gency has determined technical glyphosate sho!ld not ca!se ac!te or chronic adverse effects to a:!atic environments. Therefore@ minimal ris* is expected to a:!atic organisms from the technical glyphosate.
=c>
Terrestrial 'lants and #:!atic 3acrophytes # seed germination?seedling emergence st!dy was cond!cted on isopropylamine salt of glyphosate C'"-/+0. =Tech> 1/A acid &asis. The res!lts indicate that C'"-/+0. applied at a rate !p to +/./ l& ai?# res!lted in M,1 A effect on the spectr!m of monocots and dicots tested. Considering the !se patterns that are terrestrial food crop and non"food crop the a&ove EEC<s were considered for eval!ating the effects to nontarget plants. The highest expos!re of /.6/6 l& a.i. =from aerial application@ mist &lower and sprin*ler irrigation> is well &elow the +/./ l& a.i.?# rate which res!lted in M ,1 A effect on the monocots and dicots tested. Therefore@ it has &een determined that the !se of glyphosate is not expected to ca!se adverse effects on seed germination?seedling emergence with the vario!s registered !se patterns. =3RID 6/+1.0/+> 4o vegetative vigor =+,0"+> plant st!dies have &een cond!cted. Based on the !se
patterns@ the method of application and the chemical properties of
glyphosate@ additional st!dies are re:!ired to eval!ate these effects on nontarget terrestrial plants. The recommended la&eling preca!tions do not precl!de off"target movement of glyphosate &y drift. To assess potential ris* to terrestrial plants the #gency is re:!iring additional terrestrial plant test data@ incl!ding res!lts from vegetative vigor testing@ droplet si7e spectr!m testing and drift field eval!ation. These data are not part of the target data &ase for reregistration. Ris* red!ction meas!res cannot &e recommended !ntil data are s!&mitted and eval!ated. If@ !pon review of the data from these st!dies@ modification in !se practices and?or preca!tionary meas!res are necessary@ the #gency will re:!ire all registrants to ma*e la&el changes as appropriate. The a:!atic EEC from direct application of 0.-, ppm was !sed to estimate expos!re. Based on the res!lts of the a:!atic macrophyte toxicity data@ the 6 day EC1/ was reported to &e as low as /.51 ppm indicating that there may &e adverse effects to nontarget a:!atic plant species. =,> Endangered Species Based on the toxicity data and the estimated expos!re@ it is not expected that endangered terrestrial or a:!atic organisms will &e affected from the !se of glyphosate on the registered !ses since the EEC<s are well &elow the endangered species criteria =&irdsV +?+/ 9C1/@ a:!atic organismsV +?,/ 9C1/ >. However@ many endangered plants may &e at ris* from the !se of glyphosate on the registered !se patterns. In addition@ as disc!ssed in the +.52 %lyphosate Registration Standard@ it was determined that &ased on ha&itat@ the Ho!ston Toad may &e at ris* from the !se of glyphosate on alfalfa.
I%(
RIS/ MANAGEMENT AN$ REREGISTRATION $E ISION
A(
$etermination of Eligi0ilit.
Section 6=g>=,>=#> of $I$R# calls for the #gency to determine@ after s!&mission of relevant data concerning an active ingredient@ whether prod!cts containing the active ingredients are eligi&le for reregistration. The #gency has previo!sly identified and re:!ired the s!&mission of the generic =i.e. active ingredient specific> data re:!ired to s!pport reregistration of prod!cts containing glyphosate active ingredients. The #gency has completed its review of these generic data@ and has determined that the data are s!fficient to s!pport reregistration of all prod!cts containing the isopropylamine and sodi!m salts of glyphosate. #ppendix B identifies the generic data re:!irements that the #gency reviewed as part of its determination of reregistration eligi&ility of glyphosate@ and lists the s!&mitted st!dies that the #gency fo!nd accepta&le. The data identified in #ppendix B were s!fficient to allow the #gency to assess the registered !ses of glyphosate and to determine that glyphosate can &e !sed witho!t res!lting in !nreasona&le adverse effects to man and the environment. The #gency therefore finds that all prod!cts containing glyphosate as the active ingredients are eligi&le for reregistration. The reregistration of partic!lar prod!cts is addressed in Section H of this doc!ment. The #gency made its reregistration eligi&ility determination &ased !pon the target data &ase re:!ired for reregistration@ the c!rrent g!idelines for cond!cting accepta&le st!dies to generate s!ch data and the data identified in #ppendix B. #ltho!gh the #gency has fo!nd that all !ses of glyphosate =isopropylamine and sodi!m salt form!lations> are eligi&le for reregistration@ it sho!ld &e !nderstood that the #gency may ta*e appropriate reg!latory action@ and?or re:!ire the s!&mission of additional data to s!pport the registration of prod!cts containing glyphosate@ if new information comes to the #gency<s attention or if the data re:!irements for registration =or the g!idelines for generating s!ch data> change. +. Eligi&ility Decision Based on the reviews of the generic data for the active ingredient glyphosate@ the #gency has s!fficient information on the health effects of glyphosate and on its potential for ca!sing adverse effects in fish and wildlife and the environment. The #gency concl!des that prod!cts containing glyphosate for all !ses are eligi&le for reregistration. The #gency has determined that glyphosate prod!cts@ la&eled and !sed as specified in this Reregistration Eligi&ility Doc!ment@ will not pose !nreasona&le ris*s or adverse effects to h!mans or the environment.
,.
Eligi&le and Ineligi&le 8ses The #gency has determined that all !ses of glyphosate are eligi&le for reregistration.
B(
Reg!lator. Position The following is a s!mmary of the reg!latory positions and rationales for glyphosate. Chere la&eling revisions are imposed@ specific lang!age is set forth in Section H of this doc!ment. +. Tolerance Re"assessment The #gency has determined that aminomethyl phosphonic acid =#3'#>@ the meta&olite of glyphosate@ no longer needs to &e reg!lated and therefore this compo!nd will &e dropped from the tolerance expression. #lso@ altho!gh the monoammoni!m salt of glyphosate is not s!&(ect to reregistration@ the availa&le data are to allow re" assessment of existing tolerances for resid!es res!lting from the application of the monoammoni!m salt of glyphosate. Tolerances 9isted 8nder 6/ C$R G+5/.026=a>B The tolerances listed in 6/ C$R G+5/.026=a> are for the com&ined resid!es of glyphosate and its meta&olite #3'# res!lting from application of the isopropylamine salt of glyphosate and?or the monoammoni!m salt of glyphosate. S!fficient data are availa&le to ascertain the ade:!acy of the esta&lished tolerances listed in 6/ C$R G+5/.026=a> forB acerolaI alfalfa@ forage@ seed@ and hayI almonds@ h!llsI articho*es@ Eer!salemI asparag!sI atemoyaI avocadosI BahiagrassI &ananasI &eets@ garden@ rootsI Berm!dagrassI &l!egrassI Brassica leafy vegeta&les gro!pI &romegrassI &!l& vegeta&les gro!pI caram&olaI carrotsI cereal grains gro!pI citr!s fr!its gro!pI coffee &eans@ greenI cloverI cotton forageI cotton hayI cottonseedI cran&erriesI c!c!r&it vegeta&les gro!pI fesc!eI figsI foliage of leg!me vegeta&les gro!pI fr!iting vegeta&les gro!pI grapesI grass forage@ fodder@ and hay gro!pI g!avasI horseradishI *iwifr!itI leafy vegeta&les gro!pI leaves of the root and t!&er vegeta&les gro!pI leg!me vegeta&les gro!pI longan fr!itI lycheeI mangoesI non" grass animal feeds gro!p@ forage and hayI orchardgrassI papayasI parsnipsI passion fr!itI pean!tsI pean!ts@
vinesI pineappleI pistachioI pome fr!its gro!pI radishesI r!ta&agasI ryegrassI sapodillaI sapoteI small fr!its and &erries gro!pI soy&eansI soy&ean@ forageI stone fr!its gro!pI s!gar appleI s!gar &eetsI sweet potatoesI timothyI tree n!ts gro!pI t!rnip rootsI wheatgrassI and yams. Certain commodity definitions of the a&ove tolerances are not in accordance with the definitions listed in Ta&le II of S!&division I see the tolerance re"assessment ta&le on page 20 for modifications in commodity definitions. The esta&lished crop gro!p tolerances for the now"o&solete Dseed and pod vegeta&lesD =/., ppm> and Dseed and pod vegeta&les@ forage and hayD =/., ppm> are inappropriate and are to &e replaced with Dleg!me vegeta&les gro!p =except soy&eans>D and Dleg!me vegeta&les gro!p@ foliage of =except soy&ean forage and hay>@D respectively. Soy&eans m!st &e excl!ded from the crop gro!p tolerances &eca!se the !se pattern for soy&eans is different from other leg!me vegeta&les@ and the esta&lished tolerance for soy&eans and soy&ean forage and hay differ &y a factor Q1x from other leg!me vegeta&les. To achieve compati&ility with Codex 3R9s for selected commodities@ the following actions m!st &e ta*en =see the ta&le on page 25>B =i> increase 8.S. tolerance for leg!me vegeta&les gro!p =except soy&eans> from /., ppm to 1 ppmI and =ii> increase 8.S. tolerance for soy&ean hay from +1 ppm to ,/ ppm. The individ!al tolerances for cran&erries =/., ppm> and grapes =/., ppm> sho!ld &e revo*ed since these fr!its are covered &y the crop gro!p tolerance =/., ppm> for small fr!its and &erries. The tolerance for cotton hay is to &e revo*ed since this is not a raw agric!lt!ral commodity of cotton.
Tolerances for wheat@ grain and wheat@ straw at 6 and 51 ppm@ respectively@ have &een proposed =''/$0521?$#',H1201>. Chen these tolerances have &een esta&lished@ the tolerances for the cereal grains gro!p and the cereal grains gro!p@ forage@ fodder@ and straw sho!ld &e modified to Dcereal grains gro!p =except wheat>D and Dcereal grains gro!p@ forage@ fodder@ and straw =except wheat straw>D@ respectively. To achieve compati&ility with the Codex 3R9 for wheat grain@ the 8.S. tolerance sho!ld &e esta&lished at 1 ppm =see the ta&le on page 25>. The existing and conflicting tolerances for alfalfa =,// ppm>@ alfalfa fresh and hay =/., ppm>@ clover =,// ppm>@ and forage leg!mes =except soy&eans and pean!tsI /.6 ppm> sho!ld &e deleted. Concomitant with the deletion of these tolerances@ a tolerance of +// ppm for resid!es in or on the non"grass animal feeds gro!p@ forage and hay@ is to &e esta&lished. The availa&le data from alfalfa@ lespede7a@ and trefoil will s!pport this crop gro!p tolerance. The esta&lished tolerances for Dforage grassesD =/., ppm>@ Dgrasses@ forageD =/., ppm>@ Bahiagrass =,// ppm>@ Berm!dagrass =,// ppm>@ &l!egrass =,// ppm>@ &romegrass =,// ppm>@ fesc!e =,// ppm>@ orchardgrass =,// ppm>@ ryegrass =,// ppm>@ timothy =,// ppm>@ and wheatgrass =,// ppm> is to &e deleted. Concomitant with the deletion of these tolerances@ a tolerance for resid!es in on or on the grass forage@ fodder@ and hay gro!p is to &e esta&lished at +// ppm. The availa&le data indicate that following registered !se@ resid!es in or on the grass forage@ fodder@ and hay gro!p will not exceed +// ppm. Individ!al tolerances exist for resid!es in or on salsify and the following tropical?s!&tropical cropsB &readfr!itI canistelI cherimoyaI cocoa &eansI cocon!tI datesI genipI (a&otica&aI (ac*fr!itI persimmonsI sapote =&lac* and white>I so!rsopI and tamarind. There are c!rrently no registered !ses of glyphosate on these crop sites. These tolerances will &e revo*ed. # tolerance of ,// ppm has recently &een esta&lished for resid!es in or on soy&ean straw =$R 6,-/+@ .?+2?.,>. However@ this tolerance is to &e revo*ed since this is not a raw agric!lt!ral commodity of soy&eans. The tolerance for soy&eans@ hay sho!ld &e raised to cover this desiccant !se. The expression negligi&le resid!es =4> sho!ld &e deleted. $or a complete listing of appropriate commodity definition changes and
recommendations@ see the ta&le on page 20.
Tolerances 9isted 8nder 6/ C$R G+5/.026=&>B The tolerances listed in 6/ C$R G+5/.026=&> are for the com&ined resid!es of glyphosate and its meta&olite #3'# res!lting from application of the glyphosate isopropylamine salt and?or glyphosate monoammoni!m salt for her&icidal and plant growth reg!lator p!rposes and?or the sodi!m ses:!i salt for plant reg!lator p!rposes. S!fficient data are availa&le to ascertain the ade:!acy of the esta&lished tolerances listed in 6/ C$R G+5/.026=&> forB liver and *idney of cattle@ goats@ hogs@ horses@ po!ltry@ and sheepI pean!tsI pean!ts@ hayI pean!ts@ h!llsI s!garcaneI fishI and shellfish. See the ta&le on page 20 for modifications in commodity definitions. Tolerances 9isted 8nder 6/ C$R G+5/.026=c>B The tolerances listed in 6/ C$R G+5/.026=c> are for the com&ined resid!es of glyphosate and its meta&olite #3'# res!lting from the !se of irrigation water containing resid!es of /.1 ppm following applications on or aro!nd a:!atic sites@ and are esta&lished at /.+ ppm. The #gency<s ffice of Cater has esta&lished a maxim!m contaminant level =3C9> of /.- ppm for glyphosate per se in drin*ing water =$R 4oticeB Hol. 1-@ 4o. +05@ page 0+--2@ dated E!ly +-@ +..,>. S!fficient data are availa&le to ascertain the esta&lished tolerances listed in 6/ C$R G+5/.026=c> for the crop gro!pings Brassica leafy vegeta&les gro!pI &!l& vegeta&les gro!pI cereal grains gro!pI citr!s fr!its gro!pI c!c!r&it vegeta&les gro!pI foliage of leg!me vegeta&les gro!pI forage@ fodder@ and straw of the cereal grains gro!pI fr!iting vegeta&les gro!pI grass forage@ fodder and hay gro!pI leafy vegeta&les gro!pI leaves of the root and t!&er vegeta&les gro!pI leg!me vegeta&les gro!pI non" grass animal feeds gro!p@ forage and hayI pome fr!its gro!pI root and t!&er vegeta&les gro!pI stone fr!its gro!pI tree n!ts gro!pI and the individ!al commodities avocados@ cottonseed@ and hops. See the ta&le on page 20 for modifications in commodity definitions. Tolerances 9isted 8nder 6/ C$R G+51.01//B The tolerances listed in 6/ C$R G+51.01//=+> are for the com&ined resid!es of glyphosate and its meta&olite #3'# res!lting from the
application of the glyphosate for her&icidal p!rposes and?or the sodi!m ses:!i salt for plant reg!lator p!rposes. S!fficient data are availa&le to ascertain the ade:!acy of the esta&lished food additive tolerances listed in 6/ C$R G+51.01//=+> for s!garcane@ molasses. See the ta&le on page 20 for modifications in commodity definitions. The tolerances listed in 6/ C$R G+51.01//=,> are for the com&ined resid!es of glyphosate and its meta&olite #3'# res!lting from the application of the isopropylamine salt of glyphosate for her&icidal p!rposes. S!fficient data are availa&le to ascertain the ade:!acy of the esta&lished food additive tolerances listed in 6/ C$R G+51.01//=,> for olives =imported>@ palm oil@ dried tea and instant tea. See the ta&le on page 20 for modifications in commodity definitions. # +,"ppm food additive tolerance for wheat milling fractions =except flo!r> has &een proposed =$#',H1201>. To achieve compati&ility with the Codex 3R9 for wheat &ran@ !nprocessed@ the 8.S. tolerance sho!ld &e esta&lished at 6/ ppm =see the ta&le on page 25>. Tolerances G+52.01//B 9isted 8nder 6/ C$R
The tolerances listed in 6/ C$R G+52.01//=a> are for the com&ined resid!es of glyphosate and its meta&olite #3'#. S!fficient data are availa&le to ascertain the ade:!acy of the esta&lished feed additive tolerances listed in 6/ C$R G+52.01//=a> for dried citr!s p!lp and soy&ean h!lls. See the ta&le on page 20 for modifications in commodity definitions. # tolerance has recently &een esta&lished at +./ ppm for the com&ined resid!es of glyphosate and #3'# in citr!s@ molasses =$R 6,-/+@ .?+2?.,>. Existing tolerances of glyphosate are c!rrently esta&lished in the
Title 6/ of the Code of $ederal Reg!lations@ G+5/.026. The reassessment of the esta&lished tolerances is set forth in the Tolerance Reassessment Ta&le as follows.
5ommodi!y
5urren! 9olerance 'ppm(
9olerance 2 -eassessmen! 'ppm(
5ommen!"Correct Commodit% De!inition
Tolerances listed under 1$06'7)(a)B %cerola %l al a %l al a, resh and hay 5lover @orage legumes 'e>cep! soybeans and peanu!s( %lmond hulls %r!ichokes, :erusalem %sparagus %!emoya %vocados ;ahiagrass ;ermudagrass ;luegrass ;romegrass @escue @orage grasses 4rasses, orage &rchardgrass -yegrass 9imo!hy Ahea!grass ;ananas ;ee!s ;ee!s, sugar ;read rui! 5anis!el 5arambola 5arro!s 5herimoya 5hicory 5i!rus rui!s 5ocoa beans 5oconu! 5o ee beans 5o!!on, orage 0D2 200D0 0D2 200D0 0D# 1 0D2 0D5 0D2 0D2 200D0 200D0 200D0 200D0 200D0 0D2 0D2 200D0 200D0 200D0 200D0 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D1 1 15 -evoke -evoke -evoke ,o regis!ered uses Chicor%& roots Citrus !ruits group ,o regis!ered uses ,o regis!ered uses Co!!ee beans& green -evoke -evoke 'eets& garden& roots Sugar beets ,o regis!ered uses ,o regis!ered uses -evoke and es!ablish a! Non"grass animal !eeds group& !orage and ha% 100
lmonds& hulls
-evoke and es!ablish a! Grass !orage& !odder& and ha% group 100
5ommodi!y 5o!!on, hay 5o!!onseed 5ranberries +a!es @igs @orage grasses 4rasses, orage @rui!s, small and berries 4enip 4rain crops 4rapes 4uavas <orseradish :abo!icaba :ack rui! ?iwi rui! =ea y vege!ables
5urren! 9olerance 'ppm( 15 15 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D1 0D2 0D2 0D2 0D2 0D2 0D2 0D2
9olerance 2 -eassessmen! 'ppm( -evoke
5ommen!"Correct Commodit% De!inition ,o! in 9able **, 2ubdivision &, 8%4 5overed under small rui!s and berries group ,o regis!ered uses (orage& !odder& and straw o! cereal grains group )except wheat straw* Small !ruits and berries group
-evoke -evoke 0D2
-evoke
,o regis!ered uses Cereal grains group )except wheat*
-evoke
5overed under small rui!s and berries group
-evoke -evoke 0D1
,o regis!ered uses ,o regis!ered uses see 5ode> <armoni3a!ion 9able $ea!% vegetables )except 'rassica* group and $eaves o! root and tuber vegetables group $ongan !ruit Sapote +ree nuts group
=ongan =ychee /amy sapo!e /angoes ,u!s &lives 8apayas 8arsnips 8assion rui! 8eanu!, orage 8ersimmons
0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D5 0D2 -evoke
,arsnips& roots ,eanuts& vines ,o regis!ered uses
5ommodi!y 8ineapple 8is!achio nu!s 8ome rui!s 8o!a!oes -adishes -u!abagas 2alsi y 2apodilla 2apo!e, black 2apo!e, whi!e 2eed and pod vege!ables
5urren! 9olerance 'ppm( 0D1 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2 0D2
5ommen!"Correct Commodit% De!inition ,ineapples ,istachios ,ome !ruits group -adishes& root -utabagas& root
-evoke -evoke -evoke 5
,o regis!ered uses ,o regis!ered uses ,o regis!ered uses see 5ode> harmoni3a!ion 9ableO $egume vegetables group )except so%beans* (oliage o! legume vegetables group )except so%bean !orage and ha%* ,o regis!ered uses
2eed and pod vege!ables, orage 2eed and pod vege!ables, hay 2oursop 2oybeans 2oybeans, orage 2oybeans, hay 2oybeans, s!raw 2!one rui! 2ugar apple 2wee! po!a!oes 9amarind 9urnips 1ege!ables, bulb 1ege!ables, cucurbi! 1ege!ables, rui!ing 'e>cep! cucurbi!s( group 1ege!ables, lea y, ;rassica 'cole( Pams Ahea!, grain Ahea!, s!raw
0D2 0D2 0D2 20 15 15 200 0D2 0D2 0D2 0D2 0D2 0D2 0D5 0D1 0D2 0D2 ,"% ,"%
0D2
-evoke
200 -evoke
-aised !o cover desiccan! useD ,o! in 9able **, 2ubdivision &, 8%4 Stone !ruits group
-evoke
,o regis!ered uses +urnips& roots 'ulb vegetables group Cucurbit vegetables group (ruiting vegetables group 'rassica lea!% vegetables group
5D0 $5 'proposed(
see 5ode> harmoni3a!ion 9able
5ommodi!y
5urren! 9olerance 'ppm(
5ommen!"Correct Commodit% De!inition
Tolerances listed under )0 +,* C1$06'7)(2)B 5a!!le, kidney 5a!!le, liver @ish 4oa!s, kidney 4oa!s, liver <ogs, kidney <ogs, liver <orses, kidney <orses, liver 8eanu!s 8eanu!, hay 8eanu!, hulls 8oul!ry, kidney 8oul!ry, liver 2heep, kidney 2heep, liver 2hell ish 2ugarcane 0D5 0D5 0D25 0D5 0D5 0D5 0D5 0D5 0D5 0D1 0D5 0D5 0D5 0D5 0D5 0D5 3D0 2D0 Tolerances listed under )0 +,* 1$06'7)(c)B %vocados 5i!rus 5o!!onseed 5ucurbi!s @orage grasses @orage legumes @rui!ing vege!ables 4rain crops 0D1 0D1 0D1 0D1 0D1 0D1 0D1 0D1 Cucurbit vegetables group Grass !orage& !odder& and ha% group Non"grass animal !eeds group& !orage and ha% (ruiting vegetables group Cereal grains group and (orage& !odder& and straw o! cereal grains group Citrus !ruits group ,eanuts& ha% ,eanuts& hulls 1D0 1D0 see 5ode> harmoni3a!ion 9able see 5ode> harmoni3a!ion 9able 2D0 2D0 see 5ode> harmoni3a!ion 9able see 5ode> harmoni3a!ion 9able
<ops
0D1
5ommodi!y =ea y vege!ables
5urren! 9olerance 'ppm( 0D1
5ommen!"Correct Commodit% De!inition $ea!% vegetables )except 'rassica* group and 'rassica )cole* lea!% vegetables group +ree nuts group ,ome !ruits group -oot and tuber vegetables group and $eaves o! root and tuber vegetables group and 'ulb vegetables group $egume vegetables group and (oliage o! legume vegetables group Stone !ruits group
,u!s 8ome rui!s -oo! crop vege!ables
0D1 0D1 0D1
2eed and pod vege!ables
0D1
2!one rui!
0D1 Tolerances listed under )0 +,* C1$%6'%00(a)(1)B
/olasses, sugarcane
30D0 Tolerances listed under )0 +,* C1$%6'%00(a)(!)B
Sugarcane& molasses
&il, palm &lives, impor!ed 9ea, dried 9ea, ins!an! Ahea! milling rac!ions 'e>cep! lour(
0D1 0D1 1D0 7D0 ,"% -evoke #0
,alm oil& re!ined
,o! in 9able **, 2ubdivision &, 8%4 see 5ode> harmoni3a!ion 9able
Tolerances listed under )0 +,* C1$76'%00(a)B 5i!rus, pulp, dried 5i!rus molasses 2oybean hulls 1D0 1D0 100 Citrus& molasses So%beans& hulls
1 9olerances are or !he combined residues o glyphosa!e and i!s me!aboli!e %/8%D 2 9olerances are now or glyphosa!e per seD
5ommodi!y /-= '2!ep( 'mg"kg( BD2D 9olerance C DET H#R3 4IN#TI 4 T#B9E 'ppm(
Several maxim!m resid!e limits =3R9s> for glyphosate have &een esta&lished &y Codex in vario!s commodities. The Codex 3R9s =c!rrently expressed in terms of glyphosate per se> and applica&le 8.S. tolerances =expressed in terms of the com&ined resid!es of glyphosate and its meta&olite #3'#> are listed in the ta&le &elow. The #gency has determined that #3'# no longer needs to &e reg!lated and therefore will &e deleted from the tolerance expression. Based on this determination@ the expression of the 8.S. tolerances and the Codex 3R9s will &e harmoni7ed@ and &oth will now &e expressed in terms of glyphosate per se. Codex 3R9s and applica&le 8.S. tolerances. Recommendations for compati&ility are &ased on concl!sions following reassessments of 8.S. tolerances =see Tolerance Reassessment Ta&le@ a&ove>.
-ecommenda!ion
;arley ;eans 'dry( 5a!!le mea! 5a!!le milk 5a!!le, edible o al 5o!!onseed 0ggs <ay or odder 'dry( o grasses ?iwi rui! /ai3e &a!s 8eas 'dry( 8ig mea! 8ig, edible o al 8oul!ry mea! -ape seed -ice
20 '5J=( 2 '5J=(
0D1 '5ereal grains group, e>cep! whea!( 0D2 '=egume vege!ables group, e>cep! soybeans(
0D1 '5J=( 0D1 '5J=( 2 '5J=( 0D5 '5a!!le, liver Q kidney( 15 increase BD2D !olerances 0D5 '5J=( 0D1 '5J=( 50 '5J=( 0D1 '5J=( 0D1 '5J=( 20 '5J=( 5 '5J=( 100 '4rass orage, odder, and hay group( 0D2 0D1 0D1 '5ereal grains group, e>cep! whea!( 0D2 '=egume vege!ables group, e>cep! soybeans( increase BD2D !olerance decrease BD2D !olerance
0D1 '5J=( 1 '5J=( 0D5 '<ogs, liver Q kidney( increase BD2D !olerances 0D1 '5J=( 10 '5J=( 0D1 '5J=( 0D1 '5ereal grains group, e>cep! whea!(
5ommodi!y 2orghum 2oya bean odder 2oya bean orage 'green( 2oya bean 'dry( 2oya bean 'imma!ure seeds( 2!raw and odder 'dry( o cereal grains 2wee! corn 'corn-on-!he-cob( Ahea! Ahea! bran, unprocessed Ahea! lour Ahea! whole meal
/-= '2!ep( 'mg"kg( 0D1 '5J=( 20 '2!ep $( 5 5 '2!ep $( '2!ep $(
BD2D 9olerance 'ppm( 0D1 '5ereal grains group, e>cep! whea!( 15 '2oybeans, hay( 15 '2oybeans, orage( 20 '2oybeans(
-ecommenda!ion
0D2 '5J=( 100 '5J=( 0D1 '5J=( 5 '5J=( 0D2 '@orage, odder, and s!raw o cereal grains group, e>cep! whea! s!raw( 0D1 '5ereal grains group, e>cep! whea!( # 'proposed( 12 'proposed( increase BD2D !olerance proposal increase BD2D !olerance proposal
#0 '2!ep 6( 0D5 '2!ep $( 5 '2!ep $(
12 'proposed(
The following concl!sions can &e made regarding efforts to harmoni7e the 8.S. tolerances with the Codex 3R9sB
W W
Compati&ility &etween the 8.S. tolerances and permanent Codex 3R9s exists in or onB corn =field and sweet>I riceI and sorgh!m. The levels of 8.S. tolerances sho!ld &e increased@ toxicological and DRES considerations permitting@ to achieve compati&ility with the Codex 3R9s in or on the following commoditiesB =i> liver and *idney of cattle =from /.1 to ,./ ppm>I =ii> liver and *idney of hogs =from /.1 to +./ ppm>I and =iii> leg!me vegeta&les gro!p =except soy&eans> =from /., to 1 ppm>I The level of the 8.S. tolerance sho!ld &e decreased to achieve compati&ility with the Codex 3R9s in or on *iwifr!it =from /., to /.+ ppm>. The 8.S. tolerances in or on the following commodities were &ased on registered !se patterns in the 8.S. and cannot &e lowered to achieve compati&ility with the Codex 3R9sB =i> grass forage@ fodder@ and hay gro!pI =ii> soy&eansI and =iii> soy&eans@ forage. Cheat grain and wheat &ran tolerances of 6 and +, ppm@ respectively@ have &een proposed. To achieve compati&ility with Codex@ these tolerance levels sho!ld &e increased@ toxicological and DRES considerations permitting@ to 1 and 6/ ppm@ respectively.
Cide differences =Q1x> exist &etween the 8.S. tolerances and permanent Codex 3R9s in or on the following commoditiesB &arleyI &eans =dry>I soy&eans@ hayI cottonseedI oatsI forage@ fodder@ and straw of cereal grains. The decision to harmoni7e resid!e levels in or on these commodities cannot &e made at this time. 4o :!estions of compati&ility exist with respect to commodities whereB =i> no Codex 3R9s have &een esta&lished@ &!t 8.S. tolerances existI and =ii> Codex 3R9s have &een esta&lished@ &!t 8.S. tolerances do not exist.
,.
9a&eling Rationale Chile st!dies show that glyphosate is no more than slightly toxic to &irds and is practically non"toxic to fish and honey&ees@ a toxic inert in glyphosate end !se prod!cts necessitates the la&elling of some prod!cts Dtoxic to fishD since some glyphosate prod!cts are applied directly to a:!atic environments.
0.
Endangered Species Statement The #gency does have concerns regarding expos!re of endangered plant species to glyphosate. In the E!ne +.52 Registration Standard@ the #gency disc!ssed cons!ltations with the 8S $ish and Cildlife Service =$CS> on ha7ards to crops@ rangeland@ silvic!lt!ral sites@ and the Ho!ston toad which may res!lt from the !se of glyphosate. Beca!se a (eopardy opinion res!lted from these cons!ltations@ the agency imposed endangered species la&eling re:!irements in the Registration Standard to mitigate the ris* to endangered species. Since that time@ additional plant species have &een added to the list of endangered species. #t the present time@ E'# is wor*ing with the $CS and other federal and state agencies to develop a program to avoid (eopardi7ing the contin!ed existence of all listed species &y the !se of pesticides. Chen the Endangered Species 'rotection 'rogram is implemented and s!&se:!ent g!idance is given@ endangered species la&eling amendments may &e re:!ired on affected end"!se prod!cts. 9a&eling statements for end !se prod!cts will li*ely refer !sers to co!nty specific &!lletins specifying detailed limitations on !se to protect endangered species.
%(
A TIONS RE1'IRE$ BY REGISTRANTS

This section specifies the data re:!irements and responses necessary for the reregistration of &oth man!fact!ring"!se and end"!se prod!cts. A( Man!fact!ring2'se Prod!cts
+.
#dditional %eneric Data Re:!irements
The generic data &ase s!pporting the reregistration of glyphosate for the a&ove eligi&le !ses has &een reviewed and determined to &e s!&stantially complete. The #gency will &e calling in data on processed potatoes in a separate DCI. However@ the following additional generic data are re:!ired at this time. These additional generic data are not part of the target data &ase for glyphosate and do not affect the reregistration eligi&ility of glyphosate. =See #ppendices for the %eneric Data Call"In 4otice.> ;a3e o1 Study
9ier ** 1ege!a!ive 1igor +rople! 2i3e 2pec!rum +ri ! @ield 0valua!ion
Guideline ;u32er
123-1 201-1 202-1
,.
9a&eling Re:!irements for 3an!fact!ring"8se 'rod!cts Effl!ent Discharge 9a&eling Statement
#ll man!fact!ring"!se or end"!se prod!cts that may &e contained in an effl!ent discharged to the waters of the 8nited States or m!nicipal sewer systems m!st &ear the following revised effl!ent discharge la&eling statement. DDo not discharge effl!ent containing this prod!ct into la*es@ streams@ ponds@ est!aries@ oceans or other waters !nless in accordance with the re:!irements of a 4ational 'oll!tant Discharge Elimination System =4'DES> permit and the permitting a!thority has &een notified in writing prior to discharge. Do not discharge effl!ent containing this prod!ct to sewer systems witho!t previo!sly notifying the local sewage treatment plant a!thority. $or g!idance contact yo!r State Cater Board or Regional ffice of the E'#.D #ll affected prod!cts distri&!ted or sold &y registrants and distri&!tors =s!pplemental registrants> m!st &ear the a&ove la&eling &y cto&er +@ +..1. #ll prod!cts distri&!ted or sold &y persons other than registrants or s!pplemental registrants after cto&er +@ +..- m!st &ear the correct la&eling. Refer to 'R 4otice .0"+/ or 6/ C$R +1,.62=a>=+> for additional information. B( +. End2'se Prod!cts #dditional 'rod!ct"Specific Data Re:!irements Section 6=g>=,>B> of $I$R# calls for the #gency to o&tain any needed prod!ct" specific data regarding the pesticide after a determination of eligi&ility
has &een
made. The prod!ct specific data re:!irements are listed in #ppendix %@ the 'rod!ct Specific Data Call"In 4otice. Registrants m!st review previo!s data s!&missions to ens!re that they meet c!rrent E'# acceptance criteria =#ppendix $I #ttachment E> and if not@ commit to cond!ct new st!dies. If a registrant &elieves that previo!sly s!&mitted data meet c!rrent testing standards@ then st!dy 3RID n!m&ers sho!ld &e cited according to the instr!ctions in the Re:!irement Stat!s and Registrants Response $orm provided for each prod!ct. ,. 9a&eling Re:!irements for End"8se 'rod!cts The la&els and la&eling of all prod!cts m!st comply with E'#<s c!rrent reg!lations and re:!irements as specified in 6/ C$R G+12.+/ and other applica&le doc!ments. 'lease follow the instr!ctions in the 'esticide Reregistration Hand&oo* with respect to la&els and la&eling. $!rthermore@ the following additional la&eling m!st &e present on glyphosate end"!se prod!ct la&els. a. 4ona:!atic DDo not apply directly to water@ to areas where s!rface water is present or to intertidal areas &elow the mean high water mar*. Do not contaminate water when disposing of e:!ipment washwaters and rinsate.D &. #:!atic DDo not contaminate water when disposing of e:!ipment washwaters and rinsate. Treatment of a:!atic weeds can res!lt in oxygen loss from decomposition for dead plants. This loss can ca!se fish *ills.D c. Cor*er 'rotection Standard Compliance #ny prod!ct whose la&eling reasona&ly permits !se in the commercial or research prod!ction of an agric!lt!ral plant on any farm@ forest@ n!rsery@ or greenho!se m!st comply with the la&eling re:!irements of 'R 4otice .0" -@ D9a&eling Revisions Re:!ired &y the Cor*er 'rotection Standard =C'S>@ and 'R 4otice .0"++@ DS!pplemental %!idance for 'R 4otice .0"-@D which reflect the re:!irements of E'#<s la&eling reg!lations for wor*er protection statements =6/ C$R part +12@ s!&part R>. These la&eling revisions are necessary to implement the Cor*er 'rotection Standard for #gric!lt!ral
'esticides =6/ C$R 'art +-/> and m!st &e completed in accordance with@ and within the deadlines
specified in@ 'R 4otices .0"- and .0"++. 8nless otherwise specifically directed in this RED@ all statements re:!ired &y 'R 4otices .0"- and .0"++ are to &e on the prod!ct la&eling exactly as instr!cted in those notices. #fter #pril ,+@ +..6@ except as otherwise provided in 'R 4otices .0"and .0"++@ all prod!cts within the scope of those notices m!st &ear C'S 'R" 4otice" complying la&eling when they are distri&!ted or sold &y the primary registrant or any s!pplementally registered distri&!tor. #fter cto&er ,0@ +..1@ except as otherwise provided in 'R 4otices .0"- and .0"++@ all prod!cts within the scope of those notices m!st &ear C'S 'R" 4otice"complying la&eling when they are distri&!ted or sold &y any person. 'ersonal 'rotective E:!ipment Do not add any additional personal protective e:!ipment re:!irements to the la&els of glyphosate end"!se prod!cts@ however@ any existing personal protective e:!ipment on those la&els m!st &e retained. Entry Restrictions Prod!cts not Primaril. Intended for Home 'se 'ses )it*in t*e Sco"e of t*e )PS: # +,"ho!r restricted entry interval =REI> is re:!ired for all !ses within the scope of the C'S =see 'R 4otice .0"-> on all end"!se prod!cts@ except those intended primarily for home !se =see tests in 'R 4otice .0"- and .0"++>. This REI sho!ld &e inserted into the standardi7ed REI statement re:!ired &y 'R 4otice .0"-. The personal protective e:!ipment for early entry sho!ld &e the ''E re:!ired for applicators of glyphosate@ except any applicator re:!irement for an apron or respirator is waived. This ''E sho!ld &e inserted into the standardi7ed early entry ''E statement re:!ired &y 'R 4otice .0"-.D Sole2acti+e2ingredient end"!se prod!cts that contain glyphosate m!st &e revised to adopt the entry restrictions set forth in this section. #ny conflicting entry restrictions on their c!rrent la&eling m!st &e removed. M!lti"le2acti+e2ingredient end"!se prod!cts that contain glyphosate m!st compare the entry restrictions set forth in this section to the entry restrictions on their c!rrent la&eling and retain the more protective. # specific time" period in ho!rs or days is considered more protective than Dsprays have driedD or Dd!sts have settled.D
'ses Not )it*in t*e Sco"e of t*e )PSB Do not add any additional entry restrictions for !ses not within the scope of the C'S@ however@ any entry restrictions on the c!rrent prod!ct la&eling for those !ses m!st &e retained. Prod!cts Primaril. Intended for Home 'se: $or prod!cts primarily intended for home !se =see tests in 'R 4otice .0"- and .0"++>@ do not add any additional entry restrictions for s!ch prod!cts@ however@ any entry restrictions on the c!rrent prod!ct la&eling m!st &e retained. ( E3isting Stoc4s Registrants may generally distri&!te and sell prod!cts &earing old la&els?la&eling for ,2 months from the date of the iss!ance of this RED. 'ersons other than the registrant may generally distri&!te or sell s!ch prod!cts for 1/ months from the date of the iss!ance of this RED. However@ existing stoc*s time frames will &e esta&lished case"&y"case@ depending on the n!m&er of prod!cts involved@ the n!m&er of la&el changes@ and other factors. Refer to DExisting Stoc*s of 'esticide 'rod!ctsI State of 'olicyDI $ederal Register@ Hol!me 12@ 4o. +,0@ E!ne ,2@ +..+. The #gency has determined that registrants may distri&!te and sell glyphosate prod!cts &earing old la&els?la&eling for ,2 months from the date of iss!ance of this RED. 'ersons other than registrants may distri&!te or sell s!ch prod!cts for 1/ months from the date of iss!ance of this RED.
%I( APPEN$I ES
1D ?olded re erences were reviewed on #"26"90D Bnbolded re erences were reviewed in !he -esidue 5hemis!ry 2cience 5hap!er o !he -eregis!ra!ion 2!andard da!ed 7"15"$5D &!herwise, re erences were reviewed as no!edD
#ppendix B
Ta&le of %eneric Data Re:!irements and St!dies 8sed to 3a*e the Reregistration Decision
G'I$E TO APPEN$I& B
Appendix B contains listings of data requirements which support the reregistration for the pesticide glyphosate covered by this Reregistration Eligibility Document. It contains generic data requirements that apply to glyphosate in all products including data requirements for which a !typical formulation! is the test substance. "he data table is organi#ed in the following format$ %. Data Requiremen t &'olumn %(. "he data requirements are listed in the order in which they appear in )* '+R ,art %-.. "he reference numbers accompanying each test refer to the test protocols set in the ,esticide Assessment /uidelines which are available from the 0ational "echnical Information 1ervice -2.- ,ort Royal Road 1pringfield 3A 22%4% &5*6( ).5 7 )4-*. 8se ,atter n &'olumn 2(. "his column indicates the use patterns for which the data requirements apply. "he following letter designations are used for the given use patterns$ A B ' D E + / 9 I : ; < = 0 > 6. "errestrial food "errestrial feed "errestrial non7food Aquatic food Aquatic non7food outdoor Aquatic non7food industrial Aquatic non7food residential /reenhouse food /reenhouse non7food +orestry Residential Indoor food Indoor non7food Indoor medical Indoor residential
2.
Bibliographic citatio n &'olumn 6(. If the Agency has acceptable data in its files this column lists the identifying number of each study. "his normally is the =aster Record Identification &=RID( number but may be a !/1! number if no =RID number has been assigned. Refer to the Bibliography appendix for a complete citation of the
study.
.ata Supporting Guideline *e5uire3ents 1or the *eregistration o1 Glyphosate

RE1'IREMENT 'SE PATTERN ITATION5S6
PRO$' T
7829A 7829B 7928 7;29 7;2; 7;2< 7;2= 7;27 7;2> 7;2? 7;2@ 7;28A 7;288 7;289 7;28; 7;28>
HEMISTRY
all all all all all all all all all all all all all all all #C onstant //+2+000 //+2+000 6/6/16/+@ //+2+000 //+2+000 //+2+000 //+2+000 //+2+000 //+2+000 //+2+000 //+2+000 6+/.2+/+@ //+2+000 //+2+000 //+2+000 //+2+000 //+2+000@ 6/11.0/+ 6+1-02/+@ ///0.+6,@ ///2+110@ ///6//50@ ///2+111@ ///1+.5/@ //+/5+,.@ ///10//,@ //+/5+/,
Start( Mat( : Mnfg( Process #ormation of Im"!rities Preliminar. Anal.sis olor P*.sical State Odor Melting Point Boiling Point $ensit. Sol!0ilit. %a"or Press!re $issociation "H Sta0ilit. Storage sta0ilit. OctanolB)ater Partition

RE1'IREMENT 'SE PATTERN ITATION5S6
E OLOGI AL E##E TS
>828A >829A >829B >82; >82<A >82<B >928A >928B >928 >928$ Ac!te A+ian Oral 2 1!ailB$!c4 A+ian $ietar. 2 1!ail A+ian $ietar. 2 $!c4 )ild Mammal To3icit. A+ian Re"rod!ction 2 1!ail A+ian Re"rod!ction 2 $!c4 #is* To3icit. Bl!egill #is* To3icit. Bl!egill 2 TEP #is* To3icit. Rain0o, Tro!t #is* To3icit. Rain0o, Tro!t 2 TEP #BCD$%H #BCD$%H #BCD$%H #BCD$%H #BCD% #BCD% #BCD$%H #BCD% #BCD$%H #BCD% //+/5,/6 //+/5+////-26., ///-26., //+/5,////020,5@ //+++.10 //+0200.@ %S"/+-5/,1 +1,.2@ +1,1..@ +1,2/+@ +1,-2//+/5++,@ //+/5,/1 ///-/5.1@ ///-522+@ ///-/5.-@ ///-522,@ ///-5211@ ///-5226@ ///-5212@ ///-5221@ ///-5215@ //+/5,/1@ ///-521.@ //+,6-2/@ %S/+-5/,1@ 1,.5@ +1,-22@ +1,./0@ +116-//+/5+-, ///-/5.0@ ///-5222@ ///-521-@ //+,6-2,@ ///-522/@ %S/+-5/,1@ //-5220@ +1,1.-@ +1,2//@ +1,2/,@ +1,-25 //+/5++/
>929A >929B
In+erte0rate To3icit. In+erte0rate To3icit. 2 TEP
#BCD$%H #BCD%
>92;B
Est!arineBMarine To3icit. 2 Moll!s4
#BCD

RE1'IREMENT >92; >92<B >92= 89928A 89929 89;29 8<828 Est!arineBMarine To3icit. 2 S*rim" Life Life .cle In+erte0rate .cle #is* 'SE PATTERN #BCD #BCD%H #BCD%H BD% BD% BD% #B%H //+/5+++ //+,6-20 //+/5+-+ 6/+1.0/+ 6/,02./+@ 6/,02./,@ 6/,02./0@ 6/,02./6@ 6/,02./1 6/,02./+@ 6/,02./,@ 6/,02./0@ 6/,02./6@ 6/,02./1 ///,265. ITATION5S6
Seed GerminationBSeedling Emergence A-!atic Plant Gro,t* A-!atic Plant Gro,t* Hone. Bee Ac!te ontact
TO&I OLOGY
?828 ?829 ?82< ?827 ?928A ?929 ?;28A Ac!te Oral To3icit. 2 Rat Ac!te $ermal To3icit. 2 Ra00itBRat Primar. E.e Irritation 2 Ra00it $ermal SensitiCation 2 G!inea Pig @A2$a. #eeding 2 Rodent 982$a. $ermal 2 Ra00itBRat *ronic #eeding To3icit. 2 Rodent #BCD$%H #CD$H #BCD$%H #BCD$%H ///2-/0.@ 6+6//2/+ ///2-/0.@ 6+6//2/, 6+6//2/0@ 6+6//2/6 //+0-+0-@ //+0-+05@ //+0-+0.@ //+0-+6/ ///025/0@ 6/11.6/+ ///.562/ ///.562/@ ///.05-.

RE1'IREMENT ?;28B ?;29A ?;29B ?;2;A ?;2;B ?;2< ?<29A ?<29B ?<2< ?=28 *ronic #eeding To3icit. 2 Non2 Rodent Oncogenicit. 2 Rat Oncogenicit. 2 Mo!se $e+elo"mental To3icit. 2 Rat $e+elo"mental To3icit. 2 Ra00it 92Generation Re"rod!ction 2 Rat Gene M!tation 5Ames Test6 Str!ct!ral *romosomal A0erration Ot*er Genoto3ic Effects General Meta0olism 'SE PATTERN #CD$H #CD$H #CD$H #BCD$%H #BCD$%H #CDH #BCD$%H #BCD$%H #BCD$%H #CD$%H ITATION5S6 //+2,.+,@ 6+-,5-/+@ //+100-6 6+-,5-/+@ 6+2605/+@ ///.05-. //+0/6/2@ //+1/126 ///6202, ///62020 ///5+2-6@ //+/1..1@ 6+2,+1/+ ///-52,/@ //+0,250 ///62026@ //+0,25+@ //+0,251 ///-52+.@ //+0,252@ //+0,251 6/-2-+/+@ 6/-2-+/,
EN%IRONMENTAL #ATE
87828 87829 8782; 87928 8792; 8792< 87;28 H.drol.sis P*otodegradation 2 )ater P*otodegradation 2 Soil Aero0ic Soil Meta0olism Anaero0ic A-!atic Meta0olism Aero0ic A-!atic Meta0olism Leac*ingBAdsor"tionB $esor"tion #BCD$%H #BCD% #% #B$%H CD CD #BCD //+/5+., 6+25.+/+ 6+001+/+ 6,0-,1/+ 6,0-,1/, 6,0-,1/0 //+/5+.,

RE1'IREMENT 87<28 87<29 87<2; 87=28 87=2; 87=2< Terrestrial #ield $issi"ation A-!atic #ield $issi"ation #orest #ield $issi"ation onfined Rotational ro" ro"s Acc!m!lation 2 Irrigated Bioacc!m!lation in #is* HEMISTRY RE#EREN ES ARE 'SE PATTERN #BH CD % #C CD #BCD% 6,-21//+ 6,050,/+ 6+11,5/+ 6,0-,1/6@ 6+160,/+@ 6+160,/, 6,0-,1/1@ 6/16+0/1 6+,,50/+ ITATION5S6
RESI$'E
ONTAINE$ IN THE BO$Y O# THE RE$ 'N$ER SE TION IIID B
#ppendix C
Citations Considered to &e 'art of the Data Base S!pporting the Reregistration of %lyphosate
G'I$E TO APPEN$I&
%. CONTENTS OF BIBLIOGRAPHY. "his bibliography contains citations of all studies considered relevant by E,A in arriving at the positions and conclusions stated elsewhere in the Reregistration Eligibility Document. ,rimary sources for studies in this bibliography have been the body of data submitted to E,A and its predecessor agencies in support of past regulatory decisions. 1elections from other sources including published literature in those instances where they have been considered are included. UNITS OF ENTRY. "he unit of entry in this bibliography is called a !study!. In the case of published materials this corresponds closely to an article. In the case of unpublished materials submitted to the Agency the Agency has sought to identify documents at a level parallel to the published article from within the typically larger volumes in which they were submitted. "he resulting !studies! generally have a distinct title &or at least a single sub?ect( can stand alone for purposes of review and can be described with a conventional bibliographic citation. "he Agency has also attempted to unite basic documents and commentaries upon them treating them as a single study. IDENTIFICATION OF ENTRIES. "he entries in this bibliography are sorted numerically by =aster Record Identifier or !=RID 0umber!. "his number is unique to the citation and should be uses whenever a specific reference is required. It is not related to the six7digit !Accession 0umber! which has been used to identify volumes of submitted studies &see paragraph )&d(&)( below for further explanation(. In a few cases entries added to the bibliography late in the review may be preceded by a nine character temporary identifying number is also to be used whenever specific reference is needed. FORM OF ENTRY. In addition to the =aster Record Identifier &=RID( each entry consists of a citation containing standard elements followed in the case of material submitted to E,A by a description of the earliest @nown submission. Bibliographic conventions used reflect the standard of the American 0ational 1tandards Institute &A01I( expanded to provide for certain special needs.
2.
6.
).
5-
a.
Author. Ahenever the author could confidently be identified the Agency has chosen to show a personal author. Ahen no individual was identified the Agency has shown a identifiable laboratory or testing facility as the author. Ahen no author or laboratory could be identified the Agency has shown the first submitter as the author. Document Date. "he date of the study is ta@en directly from the document. Ahen the date is followed by a question mar@ the bibliographer has deduced the date from the evidence contained in the document. Ahen the date appears as &%BCC( the Agency was unable to determine or estimate the date of the document. T t!e. In some cases it has been necessary for the Agency bibliographers to create or enhance a document title. Any such editorial insertions are contained between square brac@ets. Tra ! n" Parenthe#e#. +or studies submitted to the Agency in the past the trailing parentheses include &in addition to any self7explanatory text( the following elements describing the earliest @nown submission$ &%( 1ubmission Date . "he date of the earliest @nown submission appears immediately following the word !received!. Administrative 0umber . "he next element immediately following the word !under! is the registration number experimental use permit number petition number or other administrative number associated with the earliest @nown submission. 1ubmitter . "he third element is the submitter. authorship is de7faulted to the submitter this element is omitted. Ahen
b.
c.
d.
&2(
&6(
&)(
3olume Identification &Accession 0umbers( . "he final element in the trailing parentheses identifies the E,A accession number of the volume in which the original submission of the study appears. "he six7 digit accession number follows the symbol !'D<! which stands for !'ompany Data <ibrary!. "his accession number is in turn followed by an alphabetic
5-
suffix which shows the relative position of the study within the volume.
5-
***%-5-B
;ahrs R.A.D 'heung =.A. &%B5B( "an@ =ixes of =etolachlor &.E plus <inuron or =etribu#in plus /lyphosate771oybeansD "an@ = of =etolachlor &.E( plus <inuron or =etribu#in plus ,araquat77 1oybeans$ 0o and =inimum "illage Applications$ Report 0o. AB 5B*2B. 1ummary of studies 265.2%7B through 265.2%7E. &8npub7 lished study received =ar %4 %B5B under %**7-.6D submitted by 'iba7/eigy 'orp. /reensboro 0.'.D 'D<$265.2%7A( ;incaid <. &%B5B( =etolachlor F /lyphosate F <inuronD Dual Roundup )E F <orox -*A$ A/7A 0o. )546 I II. &8npublished study including letter dated =ay 26 %B5. from :.D. Riggleman to R ert A. ;ahrs received =ar %4 %B5B under %**7-.6D prepared in cooperation with E.I. du ,ont de 0emours G 'o. Inc. and AD' <aboratories submitted by 'iba7/eigy 'orp. /reensboro 0.' 'D<$265.2%7B( 1chnappinger =./. &%B5B( =etolachlor F /lyphosate F <inuronD Dual .E F Roundup )E F <orox -*A$ A/7A 0o. )..4 I II. &8npublished study including letter dated =ay 26 %B5. from Riggleman to Robert A. ;ahrs received =ar %4 %B5B under %**7-.6D prepared in cooperation with E.I. du ,ont de 0emours 'o. Inc. and AD' <aboratories submitted by 'iba7/eigy 'orp /reensboro 0.'.$ 'D<$265.2%7'( 1earcy 3.D 9erman D. &%B5B( =etolachlor F /lyphosate F <inuronD Dual .E F Roundup )E F <orox -*A$ A/7A 0o. ).B6 I II. &8npublished study including letter dated =ay 26 %B5. from Riggleman to Robert A. ;ahrs received =ar %4 %B5B under %**7-.6D prepared in cooperation with E.I. du ,ont de 0emours 'o. Inc. and AD' <aboratories submitted by 'iba7/eigy 'orp /reensboro 0.'.D 'D<$265.2%7D( Rose A.D Aorsham D. &%B5B( =etolachlor F /lyphosate F <inuro Dual .E F Roundup )E F <orox -*A$ A/7A 0o. )B-4 I II A. &8np lished study including letter dated =ay 26 %B5. from :.D. Rig gleman to Robert A. ;ahrs received =ar %4 %B5B under %**7prepared in cooperation with Roc@y =ount Experiment 1tation A <aboratories and E.I. du ,ont de 0emours G 'o. Inc. submit by 'iba7/eigy 'orp. /reensboro 0.'.D 'D<$265.2%7E( ;incaid <. &%B5B( =etolachlor &Dual&R( .E(D /lyphosate &Round )E(D =etribu#in &1encor -*A($ A/7A 0o. )54- I II. &8npublish study including letter dated =ay 26 %B5. from :.D. Riggleman Robert A. ;ahrs received =ar %4 %B5B under %**7-.6D prepar
***%-54*
***%-54%
***%-542
***%-546
***%-54)
5-
in cooperation with AD' <aboratories and E.I. du ,ont de 0emou G 'o. Inc. submitted by 'iba7/eigy 'orp. /reensboro 0.'. 'D<$265.2%7+( ***%-541chnappinger =./. &%B5.( =etolachlor &Dual .E(D /lyphosate &Roundup )E(D =etribu#in &1encor -*A($ A/7A 0o. )..5 I II. &8npublished study including letter dated =ay 26 %B5. from :. Riggleman to Robert ;ahrs received =ar %4 %B5B under %**7prepared in cooperation with AD' <aboratories and E.I. du ,ont de 0emours 'o. Inc. submitted by 'iba7/eigy 'orp. /reensb 0.'.D 'D<$265.2%7/( 1earcy 1.D 9erman D. &%B5B( =etolachlor &Dual .E(D /lyphosat &Roundup )E(D =etribu#in &1encor -*A($ A/7A 0o. ).B- I II. &8npublished study including letter dated =ay 26 %B5. from Riggleman to Robert A. ;ahrs received =ar %4 %B5B under %**7 -.6D prepared in cooperation with AD' <aboratories and E.I. ,ont de 0emours 'o. Inc. submitted by 'iba7/eigy 'orp. /reensboro 0.'.D 'D<$265.2%79( Rose A.D Aorsham D. &%B5B( =etolachlor &Dual .E(D /lyphosate &Roundup )E(D =etribu#in &1encor -*A($ A/7A 0o. )B-. I II A. &8npublished study including letter dated =ay 26 %B5. from Riggleman to Robert A. ;ahrs received =ar %4 %B5B under %**7 -.6D prepared in cooperation with AD' <aboratories and E.I. ,ont de 0emours G 'o. Inc. submitted by 'iba7/eigy 'orp. /reensboro 0.'.D 'D<$265.2%7I( =onsanto 'ompany &%B5)( Residues of /lyphosate Atra#ine and 1ima#ine in or on +ield 'orn /rain 1weet 'orn and 'orn +orage and +odder following a "an@ =ix ,re7emergent =inimum "ill Application of Roundup Atra#ine and 1ima#ine. &8npublished study received Dec %B %B55 under -2)76*.D 'D<$262-%.7B( 9ouseworth <.D.D 1chnappinger 9./.D 1lagows@i :.<.D et al &%B5B( "an@ =ixes of =etolachlor &4E .E( plus 1ima#ine andHor Atra#ine plus ,araquat or /lyphosate77'orn$ 1ummary of Resid Data$ Report 0o. ABR75B%*-. &8npublished study received Dec %* %B5B under %**7-.6D prepared in cooperation with 'hevron 'he ical 'o. and others submitted by 'iba7/eigy 'orp. /reensboro 0.'.D 'D<$2)%4)57A( =onsanto 'ompany &%B5)( 1ummary of Residue Data. &8npublishe study received :an %4 %B5. under -2)72.-D 'D<$2624.*7B(
***%-544
***%-545
***26664
***26-%2
***2)-*6
5-
***2526-
=onsanto 'ompany &%B5B( Analytical Residue =ethod for 07,hosphonomethylglycine &/lyphosate( and Aminomethylphosphoni acid in 1ugarcane Bagasse Raw 1ugar and =olasses. &8npubli study received Dec 2. %B5B under -2)7662D 'D<$*BB%-57B( =onsanto 'ompany &%B54( /lyphosate Residues in ,eanuts followi ,reemergent "reatment with Roundup 9erbicide. &8npublished s received +eb 22 %B.* under -2)76*.D 'D<$*BB6*47A( =onsanto 'ompany &%BCC( Analytical Residue =ethod for 07&,hosphonomethyl( glycine Aminomethylphosphonic acid and 070itroso70&phosphonomethyl( glycine in ,eanuts. &8npublished study received +eb 22 %B.* under -2)76*.D 'D<$*BB6*47B( =onsanto 'ompany &%B56( 1ummary and 'onclusion$ Residue Data &8npublished study received Dec 6* %B5- under -2)76*.D 'D<$ 22)*427A( =onsanto 'ompany &%B5)( Analytical Residue =ethod for 07,hosphonomethyl glycine and Aminomethylphosphonic acid in 1o and Aater. =ethod B dated 0ov 2% %B5). &8npublished study received 1ep 2- %B5- under 4/%45BD 'D<$*B-6-47A( =onsanto 'ompany &%B5)( Analytical Residue =ethod for 07,hosphonomethyl glycine and Aminomethylphosphonic acid in +orage and /rain. =ethod B dated =ar % %B5). &8npublished s received 1ep 2- %B5- under 4/%45BD 'D<$*B-6-47B( ;ramer R.=.D Beasley R.;.D 1teinmet# :.R.D et al. &%B5-( Interim Report on ', 45-56 Residue and =etabolism. ,art 2.$ Determination of Residues of /lyphosate and Its =etabolite in +ish$ Agricultural Research Report 0o. 65.. &pp. %7%6 onlyD unpublished study received 1ep 2- %B5- under 4/%45BD submit by =onsanto 'o. Aashington D.'.D 'D<$*B-6-47I( =onsanto 'ompany &%B5-( Analytical Residue =ethod for 07,hosphonomethylglycine and Aminomethylphosphonic acid in +is "issue. =ethod dated 1ep 2 %B5-. &8npublished study receive 1ep 2- %B5- under 4/%45BD 'D<$*B-6-47;( +in@ R. &%B5-( +inal Report$ >ne /eneration Reproduction 1tudy77=allard Duc@$ ,ro?ect 0o. %6B7%*%. &8npublished study received 1ep 24 %B5- under 4/%45BD prepared by "ruslow +arms Inc. submitted by =onsanto 'o. Aashington D.'.D 'D<$*B4).
***2..-2
***2..-6
***66B-)
***64222
***64226
***6422B
***6426%
***6462.
5-
***654.5
=onsanto 'ompany &%B54( Residues of /lyphosate Alachlor and 'yana#ine in or on +ield 'orn +orage +odder and /rain following a "an@ =ix ,re7emergent =inimum "ill Application o Roundup <asso and Blades. &8npublished study received Apr % %B5B under -2)72.-D 'D<$26.%457B( =onsanto 'ompany &%B5B( Analytical Residue =ethod for 07,hosphonomethyl /lycine Aminomethylphosphonic acid and 070itrosoglyphosate in +ield 'orn +orage +odder and /rain. =ethod dated :an 22 %B5B. &8npublished study received Apr %. %B5B under -2)72.-D 'D<$26.%457'( 'owell :.E.D "aylor A.<.D 1tran# :.<.D et al. &%B5)( +ina Report on ', 45-46 Residue and =etabolism$ ,art 2%$ Determination of ', 45-56 and ', -*)6- Residues in /rapes$ Agricultural Research Report 0o. 665. Includes undated method entitled$ Roundup and metabolite residue analytical method. &8npublished study received >ct ) %B5) under -fl-4*D submit by =onsanto 'o. Aashington D.'.D 'D<$*B)24%7A( Rueppel =.<.D 1uba <.A.D =oran 1.:.D et al. &%B5)( +inal Report on ', 45-56 Residue and =etabolism$ ,art 2*$ "he =etabolism of ', 45-56 in /rape ,lants$ Agricultural Research Report 0o. 66-. &8npublished study received >ct ) %B5) unde -+%-4*D submitted by =onsanto 'o. Aashington D.'.D 'D<$*B)24%7B( Beasley R.;.D Daniels R.:.D <auer R.D et al. &%B5)( +inal Report on ', 45-56 Residue and =etabolism77,art %5$ Determination of 'rop Residues in 'orn Aheat 1oybeans 1mall /rains 1oil and Aater$ Agricultural Research Report 0o. 62&8npublished study received :an 6% %B55 under -2)76*.D submitted by =onsanto 'o. Aashington D.'.D 'D<$*B-5.57B( 'owell :.E.D "aylor A.<.D 1tran# :.<.D et al. &%B5)( Roundu and =etabolite Residue Analytical =ethod. &8npublished study ceived %B5) under -/%-4%D submitted by =onsanto 'o. Aashingto D.'.D 'D<$*B)24)7B( 1utherland =.<.D =arvel :.".D Banduhn =.'.D et al. &%B5-( 1ummary of =etabolism 1tudies of /lyphosate in 'itrus ,lants &8npublished study received :an 24 %B54 under -2)76*.D submitted by =onsanto 'o. Aashington D.'.D 'D<$*B)B-.7B( Beasley R.;.D ;ramer R.=.D 'arstarphen B.A.D et al. &%B5-(
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1ummary of /lyphosate &Roundup( Residue 1tudies in 'itrus +rui and ,rocessed +ractions. &8npublished study received :an 24 %B54 under 4/%56)D submitted by =onsanto 'o. Aashington D. 'D<$*B-*4-7A( ***6B655 'on@in R.A.D 9annah <.9.D 1tewart E.R. &%B5-( Residue Data for Roundup on Rice and in +ish. &8npublished study received 24 %B5- under 49-%*4D submitted by =onsanto 'o. Aashington D.'.D 'D<$*B)B**7'( ;ramer R.=.D Arras D.D.D Beasley R.;.D et al. &%B5-( +ina Report on ', 45-56 Residue and =etabolism$ Agricultural Resear Report 0o. 652. &8npublished study received 1ep 2- %B5- und 4/%45BD prepared in cooperation with Aashington 1tate 8niv. an others submitted by =onsanto 'o. Aashington D.'.D 'D<$ *B-6--7A( =onsanto 'ompany &%B5-( 1torage 1tability of +ield Residue 1amples and /lyphosate7%)' "reated 'rops. &8npublished study received Aug %6 %B5- under -+%-64D 'D<$*B).447A( =onsanto 'ompany &%B5-( /lyphosate Residues in 1oybeans. &8n lished study received Aug %6 %B5- under -+%-64D 'D<$*B).447B( =onsanto 'ompany &%B5-( /lyphosate Residues in 'orn. &8npub7 lished study received Aug %6 %B5- under -+%-64D 'D<$*B).447 =onsanto 'ompany &%B5-( /lyphosate Residues in Aheat /rain. &8npublished study received Aug %6 %B5- under -+%-64D 'D<$ *B).447D( =onsanto 'ompany &%B5-( /lyphosate Residues in 1mall /rains. &8npublished study received Aug %6 %B5- under -+%-64D 'D<$ *B).447E( =onsanto 'ompany &%BCC( 1ummary and 'onclusions$ Roundup on Barley Buc@wheat >ats Rice Rye and 1orghums. &8npublished study received on un@nown date under -/%-26D 'D<$*B)*647B( =onsanto 'ompany &%B5)( Analytical Residue =ethod for 07,hosphonomethyl glycine and Aminomethylphosphonic acid in +orage and /rain. =ethod dated =ar % %B5). &8npublished stu received on un@nown date under 1/%-26D 'D<$*B)*647'( =onsanto 'ompany &%B56( Roundup =etabolite in 3arious /rains.
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Rodwell D.E.D "as@er E.:.D Blair A.=.D et al. &%B.*( "eratology 1tudy in Rats$ IRD' 0o. )*%7*-). &8npublished st including IRD' no. BBB7*2%D received =ay 26 %B.* under -2)76* prepared by International Research and Development 'orp. submitted by =onsanto 'o. Aashington D.'.D 'D<$2)2-%47A( Rodwell D.E.D "as@er E.:.D Blair =.D et al. &%B.*( "erato 1tudy in Rabbits$ IRD' 0o. )*%7*-4. &8npublished study receive =ay 26 %B.* under -2)76*.D prepared by International Resear and Development 'orp. submitted by =onsanto 'o. Aashington D.'.D 'D<$2)2-%47B( =onsanto 'ompany &%B56( Residue Data. &'ompilationD unpublis study received on un@nown date under -2)7EI72%D 'D<$2266567E( =onsanto 'ompany &%B5-( Residue Results. &8npublished study ceived :un 6 %B54 under -2)76*.D 'D<$*B4%557D( =onsanto 'ompany &%B54( Analytical Residue =ethod for 07,hosphonomethylglycine and Aminomethylphosphonic acid in /re 'offee Beans. =ethod dated =ay % %B54. &8npublished study received :un 6 %B54 under -2)76*.D 'D<$*B4%557+( =ali@ :.=.D 'urtis ".1.D =arvel :.". &%B5-( +inal Report ',45-56 Residue and =etabolismD ,art 2)$ "he =etabolism of ', 45-56 in 'offee ,lants$ Agricultural Research Report 0o. 6)) &8npublished study received :un 6 %B54 under -2)76*.D submitt by =onsanto 'o.xx Aashington D.'.D 'D<$*B4%557I( Beasley R.;.D 1teinmet# :.R.D "aylor A.<.D et al. &%B55( lytical Residue =ethod for 07,hosphonomethyl glycine and Amino methylphosphonic acid in +orage <egumes and /rasses$ Report =1<7**4%. =ethod dated :un 2. %B55. &8npublished study receiv 1ep %4 %B.* under -2)76*.D submitted by =onsanto 'o. Aashington D.'.D 'D<$*BB42-7B( Interregional Research ,ro?ect 0umber ) &%B5.( 1ummary of /lyphosate Residues in /uava. &8npublished study received 0o %B %B.* under lE2))6D 'D<$*BB56B7A( Bas#is 1.R.D 'owell :.D <ottman =.D et al. &%B.*( /lyphosat Residues in 'otton following "opical "reatment with Roundup
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9erbicide$ Report 0o. =1<7%2.6. +inal rept. Includes method dated Aug %2 %B.* entitled$ Analytical residue method for 07 &,hosphonomethyl(glycine Aminomethylphosphonic acid and 070 troso707&,hosphonomethyl(glycine in forages and grains. &8npub lished study received 0ov %2 %B.* under -2)7EI7-)D submitte =onsanto 'o. Aashington D.'.D 'D<$*BB52*7A( ***4%--***4%--B =onsanto 'ompany &%B5)( Residue Results. &8npublished study re ceived on un@nown date under -2)7EI72)D 'D<$*B-6)-7:( =onsanto 'ompany &%BCC( Analytical Residue =ethod for 07,hosphonomethyl glycine &/lyphosate( and Aminomethylphosph acid in 1ugarcane 1ugarcane <eaves Bagasse 1ugar and =olasses Irrigation Aater and 1oil. &8npublished study receiv =ar %% %B54 under -2)76*.D 'D<$*B-%)%7E( =onsanto 'ompany &%B5B( 1ummary of /lyphosate Residues in ,apaya. &8npublished study received 0ov 2* %B.* under -2)76 'D<$ *BB5-%7A( =onsanto 'ompany &%B5B( Analytical Residue =ethod for 07,hosphonomethylglycine and Aminomethylphosphonic acid in ,apaya$ ,ro?ect 0o. -*4). &8npublished study received 0ov 2* %B.* under -2)6*.D 'D<$*BB5-%7B( =onsanto 'ompany &%B44C( Analytical Residue =ethod for 07&,hosphonomethyl(7glycine Aminomethylphosphonic Acid and 070itroso70&phosphonomethyl(7glycine in +orages /rains 1oi and Aater. 8ndated method %. &8npublished study received =ay % %B55 under -2)76*.D 'D<$22B5.57'( =onsanto 'ompany &%B44C( Analytical Residue =ethod for 07&,hosphonomethyl(7glycine Aminomethylphosphonic Acid and 0itroso70&phosphonomethyl(7glycine in +orages /rains and Aate 8ndated method 2. &8npublished study received =ay %2 %B55 u -2)6*.D 'D<$22B5.57D( +ra#ier 9.A.D Rueppel =.<. &%B54( 'rop =etabolism 1tudies of 0&,hosphonomethyl(7glycine$ 070itrosoglyphosate$ Report 0o. Interim rept. &8npublished study received =ay %2 %B55 under -2)76*.D submitted by =onsanto 'o. Aashington D.'.D 'D<$ 22B5.57E( Birch =.D. &%B5*( "oxicological Investigation of ', 45-5676$ ,ro?ect 0o. J75*7B*. &8npublished study received :an 6* %B5
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=onsanto 'ompany &%B.*( Residues of /lyphosate and >ther 9erbicides in Aheat following 'hemical +allow Applications o Roundup "an@ =ix 'ombinations. Includes method dated :ul % %B and undated methods entitled$ 2 )7D in wheat forage straw a grainD Dicamba in wheat forage straw and grainD Residues of alachlor in wheat grain forage and strawD Atra#ine in wheat forage straw and grainD 'yana#ine in wheat forage straw and grainD =etribu#in and metabolites in wheat forage straw and grain. &8npublished study including published data receive Dec 2B %B.* under -2)76*.D 'D<$2)6BB*7AD 2t6BB%( <eBlanc /.A.D 1urprenant D.'.D 1leight B.9. III &%B.*( Acu "oxicity of Roundup to the Aater +lea &Daphnia magna($ Repor KBA7.*7)7464D =onsanto 1tudy 0o. B07.*7*5B. &8npublished study including letter dated +eb 2% %B.* from R. >leson to Robert +oster received Apr 2 %B.% under -2)76*.D prepared by E/ G / Bionomics submitted by =onsanto 'o. Aashington D.'.D 'D<$2))5)B7B( <eBlanc /.A.D 1urprenant D.'.D 1leight B.9. III &%B.*( A "oxicity of Roundup to Rainbow "rout &1almo gairdneri($ Report KBA7.*7)746-D =onsanto 1tudy 0o. B07.*7*5). &8npublished stu received Apr ) %B.% under -2)76*.D prepared by E/ G / Bionomics submitted by =onsanto 'o. Aashington D.'.D 'D<$ 2))5)B7D( <eBlanc /.A.D 1urprenant D.'.D 1leight B.9. III &%B.*( Acu "oxicity of Roundup to Bluegill &<epomis macrochirus($ Repor KBA7.*7)746)D =onsanto 1tudy 0o. B07.*7*5-. &8npublished study received Apr 2 %B.% under -2)76*.D prepared by E/ G / Bionomics submitted by =onsanto 'o. Aashington D.'.D 'D<$ 2))5)B7+( 1leight B.9. III &%B56( Research Report 1ubmitted to =onsa 'ompany$ Exposure of +ish to %)'7Roundup$ Accumulation Distribution and Elimination of %)'7Residues. &8npublished study received 0ov B %B56 under -2)76*.D prepared by Bionomic Inc. submitted by =onsanto 'o. Aashington D.'.D 'D<$%2*4) +in@ R. &%B56( +inal Report$ Eight7day Dietary <'-*77Bobwhite Euail$ ,ro?ect 0o. 2)%7%*4. &8npublished study received 0ov %B56 under -2)76*.D prepared by Environmental 1ciences 'orp.
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Bas#is 1.R.D 1erdy +.1.D Dubelman 1. &%B.*( /lyphosate Residues in ,asture /rasses <egumes and Alfalfa following ,ostemergent 1pot "reatment with Roundup 9erbicide$ Report 0o. =1<7%%)*. Includes method dated :ul % %B5B. &8npublished st received =ay %% %B.% under -2)76*.D submitted by =onsanto 'o. Aashington D.'.D 'D<$*5**.67A( Branch D.;.D 1tout <.D.D +ol@ R.=. &%B.%( Acute Dermal "oxicity of =on 2%6B 0+7.*7A to Rabbits$ E9< .**2B-. &8npublished study received :ul % %B.% under -2)76*.D submi by =onsanto 'o. Aashington D.'.D 'D<$*5*%5*7/( Branch D.;.D 1tout <.D.D +ol@ R.=. &%B.%( ,rimary Eye Irrit tion of =>0 2%6B 0+7.*7A to Rabbits$ E9< .**2B5. &8npublishe study received :ul % %B.% under -2)76*.D submitted by =onsant 'o. Aashington D.'.D 'D<$*5*%5*79( Branch D.;.D 1tout <.D.D +ol@ R.=. &%B.%( ,rimary 1@in Ir tation of =>0 2%6B 0+7.*7A to Rabbits$ E9< .**2B4. &8npublishe study received :ul % %B.% under -2)76*.D submitted by =onsa 'o. Aashington D.'.D 'D<$*5D%5*7I( Branch D.;.D 1tout <.D.D +ol@ R.=. &%B.%( Acute >ral "oxici of =>0 2%6B 0+7.*7AA to Rats$ E9< .**2B*. &8npublished study received :ul % %B.% under -2)76*.D submitted by =onsanto 'o Aashington D.'.D 'D<$*5*%5*7:( Branch D.;.D 1tout <.D.D +ol@ R.=. &%B.%( Acute Dermal "oxicity of =>0 2%6B 0+7.*7AA to Rabbits$ E9< .**2B%. &8npublished study received :ul % %B.% under -2)76*.D submitt by =onsanto 'o. Aashington D.'.D 'D<$*5*%5*7;( Branch D.;.D 1tout <.D.D +ol@ R.=. &%B.%( ,rimary Eye Irr tion of =>0 2%6B 0+7.*7AA to Rabbits$ E9< .**2B6. &8npublished study received :ul % %B.% under -2)76*.D submitted by =onsa 'o. Aashington D.'.D 'D<$*5*%5*7<( Branch D.;.D 1tout <.D.D +ol@ R.=. &%B.%( ,rimary 1@in Irri tation of =>0 2%6B 0+7.*7AA to Rabbits$ E9< .**2B2. &8npubli study received :ul % %B.% under -2)76*.D submitted by =onsant 'o. Aashington D.'.D 'D<$*5*%5*7=( Branch D.;.D 1tout <.D.D +ol@ R.=. &%B.%( Acute >ral "oxi
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&8npublished study received 1ep 22 %B.% under -2)76*.D prepar by BioHdynamics Inc. submitted by =onsanto 'o. Aashington D.'.D 'D<$2)-B*B7A( ***B6.5B <an@as /.R.D 9ogan /.;. &%B.%( A <ifetime +eeding 1tudy of /lyphosate &Roundup "echnical( in Rats$ ,ro?ect 0o. 552*42. &8npublished study received :an 2* %B.2 under -2)76*.D prepar by BioHdynamics Inc. submitted by =onsanto 'o. Aashington D.'.D 'D<$2)44%57AD 2)44%.D 2)44%BD 2)442*D 2)442%( /rabia@ =.'.D =ali@ :.=.D ,urdum xx.R. &%B.%( A Reinvestigation of the 1tatic Exposure of 'hannel 'atfish to %)'7<abeled /lyphosate 07&,hosphonomethyl( /lycine$ Report 0o =1<72*-4. &8npublished study including final bioconcentrati report no. 25)B5 received =ar 2 %B.2 under -2)76*.D submitte by =onsanto 'o. Aashington D.'.D 'D<$2)4.547A( :ohnson D.E.D 0air ;.,.'.D Riley :.9.D et al. &%B.2( 2%7d Dermal "oxicity 1tudy in Rabbits$ )*%7%4.D =onsanto 0o. IR7.%7 %B-. &8npublished study received Apr %2 %B.2 under -2)76*.D prepared by International Research and Development 'orp. su mitted by =onsanto 'o. Aashington D.'.D 'D<$2)522.7A( 1treet R. &%B.2( <etter sent to R. "aylor dated :ul 4 %B.2$ Roundup herbicide$ Addendum to pathology report for a three7 generation reproduction study in rats with glyphosate. &8npub7 lished study received :ul 5 %B.2 under -2)76*.D submitted b =onsanto 'o. Aashington D'D 'D<$2)55B67A( Rueppel =.D 1uba <.D 'onoyer =.D et al. &%B56( +inal Report on ', 45-56 Residue and =etabolism$ ,art %*$ "he =etabolism ', 45-56 in 1oybeans 'otton Aheat and 'orn$ Agricultural Research Report 0o. 6*). &8npublished study received 0ov %2 %B56 under )/%)))D submitted by =onsanto 'ommercial ,roducts 'o. 1t. <ouis =>D 'D<$*B6.)B7B( 'olvin <.D =iller :.D =arvel :. &%B56( +inal Report on ', 45-56 Residue and =etabolism$ ,art .$ "he /ross =etabolism of ... &', 45-567%)'( in the <aboratory Rat following a 1ingle Dose$ Agricultural Research Report 0o. 2B5. &8npublished stu received 0ov %2 %B56 under )/%)))D submitted by =onsanto 'ommercial ,roducts 'o. 1t. <ouis =>D 'D<$*B6.)B7'( 'olvin <.D =iller :.D =arvel :. &%B56( +inal Report on ', 45-56 Residue and =etabolism$ ,art B$ "he /ross Distribution o
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and =etabolite Residue =ethod Development for Animal "issues a ,roducts$ Appendix '. 8npublished study prepared by =onsanto p. /1*%5.7*%5 =onsanto 'o. &%B54( Analytical Residue =ethod for 07nitnoso707phosphonomethyl /lycine in Aater$ =ethod D. 8npublished method. 5 p. /1*%5.7*%. =onsanto 'o. &%B5.( Analytical Residue =ethod for 07nitrosoglyphosate in Aater$ =ethod 6. 8npublished =ethod. 2* p. /1*%5.7*%B 1torherr R. &%B.*( <etter sent7to E. Lager dated 1ept. %B %B.*$ /lyphosate 9,<' =ethod trial on tomatoes and cottonseed. 6 p. /1*%5.7*2* 1torherr R. &%B.%( <etter sent to =. 0elson dated :an %B %B.%$ =ethod trial on ,, K>+262B glyphosate in or on peanuts by an 9,<' procedure. 6 p. /1*%5.7*22 Lee ;. &%B5-( =emorandum to :. 'ummings dated 0ov % %B5-$ ,, K-+%-64. =ethod tryout for glyphosate on soybeans. /1*%5.7*26 Lee ;. &%B55( =emorandum to :. 'ummings dated +eb B %B55$ ,, K4+%566 and 4+%5-.. =ethod tryout for glyphosate in beef liver. 2 p. /1*%5.7*2+olmar <.D 1anders 9.D :ulin A. &%B5B( "oxicity of the herbicide glyphosate and several of its formulations to fish aquatic invertebrates. Arch. Environm. 'ontam. "oxicol. .$24B725.. /1*%5.7*2. =onsanto 'o. &%B54( Information to 1upport Establishment of a +ood Additive "olerance for /lyphosate in ,alm >il$ 1pecial Report 0o. )2). 3ol % of % 1ections A7:. 8npublished study. )% ,. Ar@ansas 'ooperative Extension 1ervice &%B.-( Recommended 'hemicals for Aeed and Brush 'ontrol =,7A) Ar@ansas. 9ill E.+. 9eath R./. 1pann :.A. and Ailliams :.D.&%B5-( <ethal Dietary "oxicities of Environmental ,ollutants to Bird 8.1.+.A.1. 1pecial 1cientific .Report77Aildlife 0o. %B%.
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1treet R. &%B.2( <etter sent ot R. "aylor dated :ul 4 %B.2$ Roundup 9erbicide$ Addendum to pathology reprot for a three generation reproduction study in rates with glyphosate. &8npublished study received :ul 5 %B.2 under -2)76*.D submitt by =onsanto 'o. Aashington D'D 'D<$2)55B67A( Reyna =. &%BB*( "wo /eneration Reproduction +eeding 1tudy w /lysophate in 1prague7Dawley Rats$ <ab ,ro?ect 0o$ =1<7%*6.5. 8npublished study prepared by =onsanto Agricultural 'o. %%;ier <.D.D +lowers <.:.D 9annah <.9. &%B5.( +inal Report on 1almonella =utagenicity Assay of /lyphosate$ "est 0o. <+75.7 &8npublished study received Apr 2- %B5B under -2)76*.D submitted by =onsanto 'o. Aashington D.'.D 'D<$26.2667B( <i A.D ;ier <.D +ol@ R. &%B.6( '9>H9/,R" /ene =utation Assa with /lyphosate$ E9< 1tudy 0o. =<7.67%--. +inal rept. &8npublished study received 0ov %- %B.6 under -2)76*.D submitted by =onsanto 'o. Aashington D'D 'D<$2-%5657B( <i A.D ;ier <.D +ol@ R. &%B.6( In vivo Bone =arrow 'ytogenetics 1tudy of /lyphosate in 1prague7Dawley Rats$ 1tu 0o. .6**.6. &8npublished study received 0ov %- %B.6 under -2 6*.D submitted by =onsanto 'o. Aashington D'D 'D<$2-%5657D 1hirasu J.D =oriya =.D >hta ". &%B5.( =icrobial =utagenicit "esting on ',45-56 &/lyphosate(. &8npublished study receive April 2- %B5B under -2)76*.D prepared by Institute of Environmental "oxicology :apan submitted by =onsanto 'o. Aashington D.'.D 'D<$26.2667A( Ridley A.D =irly ;. &%B..( "he =etabolism of /lyphosate in 1prague Dawley Rats77,art I. Excretion and "issue Distribution of /lyphosate and Its =etablites following Intravenous and > Administration$ <aboratory ,ro?ect 0o. .4%6B &=1<752%-($ R.D. 0o. .55. 8npublished study prepared by =onsanto 'o. -.5 p. 9owe R.D 'hott R.D =c'lanahan R. &%B..( =etabolism of /lyphosate in 1prague7Dawley Rats. ,art II. Identification 'haracteri#ation and Euantitation of /lyphosate and Its =etabolites after Intravenous and >ral Administration$ <aboratory ,ro?ect 0o. =1<752*4$ R.D. 0o. .55. 8npublished study prepared by =onsanto 'o. %-- p. Ridley A. Dietrich =.D +ol@ R.D et al. &%B.6( A 1tudy of
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"hompson '.D =cAllister A. &%B.6( Acute "oxicity of <iqua Ae to Rainbow "rout &1almo gairdneri($ Report K6*)*B. 8npubli study prepared by Analytical Bio7'hemistry <aboratories Inc. -% p. ;inter D.D +orbis A. &%B.6( Acute "oxicity of <I75** to Rainbow "rout &1almo gairdneri($ Report 0o. 6*)%2. 8npubli study prepared by Analytical Bio7'hemistry <aboratories Inc. )4 p. "hompson '.D =cAllister A. &%B.6( Acute "oxicity of ,assag Rainbow "rout &1almo gairdneri($ Report 0o. 6*)%2. 8npublish study prepared by Analytical Bio7'hemistry <aboratories Inc )4 p. ;inter D.D +orbis A. &%B.6( Acute "oxicity of MInert IngredientN to Rainbow "rout &1almo gairdneri($ 1tatic Bioass Report 0o. 6*)%-. 8npublished =onsanto 1tudy 0o. AB7.67%2* prepared by Analytical Bio7'hemistry <aboratories Inc. )4 Burgess D.D +orbis A. &%B.6( Acute "oxicity of <iqua7Aet to Daphnia magna$ Report 0o. 6*)%*. 8npublished study prepare Analytical Bio7'hemistry <aboratories Inc. 6- p. Burgess D.D +orbis A. &%B.6( Acute "oxicity of <I75** to Daphnia magna$ Report 0o. 6*)%6. 8npublished study prepared Analytical Bio7'hemistry <aboratories Inc. 6) p. Burgess D.D +orbis A. &%B.6( Acute "oxicity of ,assage to Daphnia magna$ Report 0o. 6*)%6. 8npublished study prepare Analytical Bio7'hemistry <aboratories Inc. 6) p. Burgess D.D +orbis A. &%B.6( Acute "oxicity of MInert IngredientN to Daphnia magna$ 1tatic Acute Bioassay Report 0o 6*)%4. 8npublished =onsanto 1tudy 0o. AB7.67%22 prepared by
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**%-B)%B ;untsman :. &%B.-( 3alidation of a 0ew Residue =ethod for Analysis of /lyphosate and Aminomethylphosphonic Acid &A=,A( 7 A Round7 robin 1tudy$ Report 0o. =1<7)24.$ :obH,ro?ect 0o. 5%46. 8n7 published study prepared by =onsanto 'o. and others. %*6 p. **%4)52B Danhaus R. &%B.4( Reanalysis of Aater 'otton 1oybeans ,asture /rasses Alfalfa and >ther <egumes for /lyphosate and Amino7 methylphosphonic Acid$ =1<7)-**. 8npublished study prepared by =onsanto 'o. .) p. )*-*24*% ;unstman :. &%B.5( /lyphosate Residues in =ilo /rain and +odder +ollowing ,reharvest Applications with Roundup 9erbicide$ =1<7 4B%B. 8npublished study prepared by =onsanto 'o. %%* p. ***4%--6 =onsanto 'ompany &%B5)( Residue Results. &8npublished study re7 ceived on un@nown date under -2)7EI72)D 'D<$*B-6)-7+( )*-*24*- =ueth =. &%B..( 1torage 1tability of /lyphosate in 'rops and Aa7 ter 7 1tatus Report$ **446**. 8npublished compilation prepared by =onsanto 'o. %)% p. )*-62**) =anning =. &%B..( 1torage 1tability 1tudy of /lyphosate and A=,A in 1wine "issues Dairy 'ow "issues and =il@ <aying 9en "issues and Eggs$ <aboratory ,ro?ect ID =1<75-%-. 8npublished study prepared by =onsanto 'ompany. 2*) p. )%B)*5*% =ueth =. &%BB%( 1torage 1tability of /lyphosate Residues in 'rop 'ommodities$ <ab ,ro?ect 0umber$ =1<7%*.)6$ %*-%. 8npublished study prepared by =onsanto Agricultural 'o. %B6 p. )*5.-6*2 =ueth =. &%B..( /lyphosate Residues in ,otatoes and ,rocessed +ractions of ,otatoes After "reatment with Roundup 9erbicide$ ,ro?ect ID. =1<75.55. 6*% p. )*.6-2*% Baron :. &%B..( /lyphosate77=agnitude of Residue on "urnip$ IR7) ,ro?ect 62*). 8npublished study prepared by IR7) 0ortheast Analytical <ab. .2 p. )*5.6%*% Baron :. &%B..( /lyphosate77=agnitude of Residue on >nions$ IR7) ,ro?ect 62*- 62*4 62*5. 8npublished study prepared by IR7) 0ortheast Analytical <ab. B5 p. )*.*2.*% Baron :. &%B..( /lyphosate 7 =agnitude of Residue on Broccoli$ ,ro?ect ID. ,R762%*. 8npublished study prepared by IR7) 0ortheast Analytical <aboratory. )2 p. **%-45B6 ;unstman :. &%B.6( /lyphosate Residues in 1oybeans and 1oybean
5-
+ractions following Recirculating 1prayer and ,reharvest "opical "reatments with Roundup 9erbicide$ Report 0o. =1<762-B$ ,ro?ec 0o. 5%46. 8npublished study prepared by =onsanto 'o. %%5 p. )*%-B)*% Beasley R. &%B.5( Determination of ', 45-56 and ', -*)6- Residues in 'itrus ,rocess +ractions$ Additional Information in Respons to the /uidance Document for /lyphosate Registration and 1peci7 fically the ,reviously 1ubmitted /lyphosate Residue 'hemistry 1tudy for 'itrus +ruits. 8npublished study prepared by =on7 santo Agricultural 'o. %2 p. ***-6**2 =onsanto 'ompany &%B.*( 1ummary$ R/lyphosateS. Includes undated method entitled$ Analysis of /lyphosate in cranberriesD undate method entitled$ /lyphosate and metaboliteD and undated method entitled$ ,rocedure for /lyphosate and Aminomethylphosphonic acid analysis of cranberries. &Reports by various sourcesD unpublished study received 1ep %. %B.* under -2)76*.D 'D<$ *BB42)7A( )*5.-6*6 Adams 1. &%B..( /lyphosate Residues in /rapes and /rape ,rocessi 'ommodities +ollowing Directed 1pray "reatment with Roundup 9erbicide$ ,ro?ect ID. =1<7.*25. 8npublished study prepared by =onsanto Agricultural 'o. %2% p. )*-*24*2 ;unstman :. &%B.5( /lyphosate Residues in 'orn /rain and +odder +ollowing ,reharvest Applications with Roundup 9erbicide$ =1<7 446.. 8npublished study prepared by =onsanto 'o. %54 p. )*-*24*) ;unstman :. &%B.5( /lyphosate Residues in 'orn /rain +ractions +ollowing ,reharvest Applications to 'orn with Roundup 9erbi7 cide$ =1<74B%5. 8npublished study prepared by =onsanto 'o. %B- p. )%)5.%*% ;unda 8. 1. &%BB*( /lyphosphate Residues in or on 'orn /rits and +lour +ollowing ,reharvest Application of Roundup 9erbicide to 'orn$ <ab ,ro?ect 0umber$ =1<7B5B5. 8npublished study prepared by =onsanto Agricultural 'o. in cooperation with "exas AG= 8niv. +ood ,rotein Research 'enter. .. p. )*-*24*% ;unstman :. &%B.5( /lyphosate Residues in =ilo /rain and +odder +ollowing ,reharvest Applications with Roundup 9erbicide$ =1<7 4B%B. 8npublished study prepared by =onsanto 'o. %%* p. )*-*24*6 ;untsman :. &%B.5( /lyphosate Residues in =ilo /rain +ractions +ollowing ,reharvest Applications to =ilo with Roundup 9erbi7 cide$ =1<75*)6. 8npublished study prepared by =onsanto 'o.
5-
%6. p. )%).)6*% Allin :. &%B.B( /lyphosate Residues in Aheat /rain and 1traw after ,reharvest "reatment with Roundup 9erbicide$ R.D. 0o. B.6. 8npublished study prepared by =onsanto Agricultural 'o. )64 p. **%-*.6- =onsanto 'o. &%B.)( T/lyphosate Residues in Aheat /rain 1traw an =illingH+ractionation ,roducts following Ropewic@ Aiper "reat7 ment with Roundup 9erbicideU. 8npublished compilation. %-. p **%*B25% =onsanto 'o. &%BCC( 'rop Residues and "olerances. &8npublished study received Apr B %B.2 under ;1 .2H% for =onsantoD 'D<$ 2)56).7B( )*-*24*% ;unstman :. &%B.5( /lyphosate Residues in =ilo /rain and +odder +ollowing ,reharvest Applications with Roundup 9erbicide$ =1<7 4B%B. 8npublished study prepared by =onsanto 'o. %%* p. )*-)%6*) =ueth =. &%B..( 3olume )$ /lyphosate Residues in Alfalfa 9ay and 1eed following 1cattered 1pot "reatment with Roundup 9erbicide <aboratory ,ro?ect 0o. =1<75).2. 8npublished study prepared by =onsanto 'o. %2% p. )*4)2)*% Baron :. &%B..( /lyphosate77=agnitude of Residue on Asparagus$ <aboratory ,ro?ect ID$ ,R 62%2. 8npublished study prepared by 0J 1tate Agricultural Experiment 1tation. 4B p. )*%)B)*% 1heldon A. &%B.4( "riphenyltin 9ydroxide77Responses to Euestions in the E,A <etter 1eptember 2) %B.4 &:acoby to 1heldon(. 8n7 published study prepared by =G" 'hemicals Inc. %- p. ***-%B.% =onsanto 'ompany &%B56( =aster 1ummary "able of ,,= Residues of /lyphosate &',45-56( and /lyphosate =etabolite &',-*)6-( in /reen 'offee Bean 1tudies 8sing a 1ingle Directed ,ost7emergent Application. &8npublished study received :un 6 %B54 under -2)76*.D 'D<$*B4%557E( )*-.*)*% Baron :. &%B..( /lyphosate77=agnitude of Residue on =ango$ ,ro?ect ID$ IR7) ,R762%6. 8npublished study prepared by IR7) 0ortheas Analytical <aboratory. 6- p. )26B.)*% 9ontis A. &%BB2( Residues of /lyphosateHA=,A in >lives and >live >il +ollowing 8se of 1ting 1E771panish +ield "rials %BB*7%BB2$ <ab ,ro?ect 0umber$ %%%-$ =<<76*2B5. 8npublished study prepared by =onsanto Agricultural 'o. 56 p.
5-
**%))6)% 1teinmet# :. &%B.)( /lyphosate Residues in ,eanuts and ,eanut +ractionation ,roducts +ollowing ,ostemergent ,olyesterHAcryli ,ipewic@ "reatments with Roundup 9erbicide$ Report 0o. =1<766B2D :obH,ro?ect 0o. 5%46. 8npublished study prepared by =onsanto 'o. in cooperation with AB' <aboratories Inc. and 'raven <abor7 atories Inc. %%4 p. )*-)%6*- ;unstman :. &%B..( 3olume -$ Irrigated 'rops 1tudy77Determination of /lyphosate Residues in 'rops Irrigation Aater 1ediment a 1oil following "reatment of Irrigation 1ource with Rodeo$ <abo7 ratory ,ro?ect 0o. =1<75466. 8npublished study prepared by =o santo Agricultural 'o. 2*6 p. )*-62**% =anning =.D Ailson /. &%B.5( Residue Determination of /lyphosat and A=,A in <aying 9en "issues and Eggs +ollowing a 2.7Day +eeding 1tudy$ <aboratory ,ro?ect ID =1<74454. 8npublished study prepared by =onsanto 'ompany. %B2 p. )*-62**2 =anning =.D Ailson /. &%B.5( Residue Determination of /lyphosat and A=,A in 1wine "issues +ollowing a 2.7Day +eeding 1tudy$ <aboratory ,ro?ect ID =1<74425. 8npublished study prepared by =onsanto 'ompany. %)5 p. )*-62**6 =anning =.D Ailson /. &%B.5( Residue Determination of /lyphosat and A=,A in Dairy 'ow "issues and =il@ +ollowing a 2.7Day +eeding 1tudy$ <aboratory ,ro?ect ID =1<7452B. 8npublished study prepared by =onsanto 'ompany. %.* p. **%-)6%% Armstrong ". 'omp. &%B.-( 1tatic =arine =ollus@ &Rangia cuneata Bioconcentration 1tudy with Aater7applied T'arbon7%)U7/lypho7 sate and !0on7aged! 1andy <oam 1oil 1ubstrate ,art I and ,art II$ 1pecial Report =1<7-%-B. 8npublished compilation prepared by =onsanto Agricultural ,roducts 'o. in cooperation with Analytical Bio7'hemistry <abs. 2B6 p. **%--%2* Armstrong ". comp. &%B.-( 1tatic 'rayfish &,rocambarus simulans +axon( Bioconcentration 1tudy with Aater7applied T'arbon %)U7 /lyophosate and !0on7aged! 1andy <oam 1oil 1ubstrate ,art I a ,art II. 8npublished compilation prepared by =onsanto 'o. 62)p.
5-
#ppendix D
9ist of #vaila&le Related Doc!ments
"he following is a list of available documents related to glyphosate. Its purpose is to provide a path to more detailed information if it is required. "hese accompanying documents are part of the Administrative Record for glyphosate and are included in the E,AVs >ffice of ,esticide ,rograms ,ublic Doc@et. %. 2. 6. ). -. 9ealth and Environmental Effects 1cience 'hapters Detailed <abel 8sage Information 1ystem &<8I1( Report /lyphosate RED +act 1heet &included in this RED( ,R 0otice B%72 &Included in this RED( ,ertains to the <abel Ingredient 1tatement 'omplete Appendix A which details the use patterns sub?ect to reregistration
+ederal publications on glyphosate are available and may be purchased from the 0ational "echnical Information 1ervice &0"I1( -2.- ,ort Royal Road 1pringfield 3A 22%4%. %. 2. ,esticide +act 1heet &0o. E,A756.7+7B67*%%( for /lyphosate Registration 1tandard for ,esticide ,roducts 'ontaining /lyphosate as the Active Ingredient &"he %B.4 Registration 1tandard($ 0"I1 1toc@ 0o. ,B.57%*62%)

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GLYPHOSATE REREGISTRATION ELIGIBILITY TEAM

'esticides and Toxic S!&stances Division #e$ra !urton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 'esticides Branch

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

Expos!re #ssessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,/ a. &. Dietary Expos!re . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,/ cc!pational and Residential . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,+

RIS/ MANAGEMENT AN$ REREGISTRATION $E ISION . . . . . . . . 1-

GLYPHOSATE RED September 1993

A TIONS RE1'IRE$ BY REGISTRANTS . . . . . . . . . . . . . . . . . . . . . . . . . . -/

A""endi3 A " A""endi3 B "

GLYPHOSATE RED September 1993

9ist of #vaila&le Related Doc!ments A""endi3 E "

GLYPHOSATE RED September 1993

GLOSSARY O# TERMS AN$ ABBRE%IATIONS

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

E&E 'TI%E S'MMARY

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

Ro!nd!p@ Rodeo@ Shac*le

=+/02/+> Type of ChemicalB 3echanism of #ctionB

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

many &roadleaf and grass weeds

GLYPHOSATE RED September 1993

=+/02/0> Type of ChemicalB 3echanism of #ctionB

modifies plant growthI hastens fr!it ripening

GLYPHOSATE RED September 1993

non-ag areas almonds

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

Empirical $orm!laB 3olec!lar CeightB C#S Registry 4o.B Sha!ghnessy 4o.B

C 0 H5 4 1 ' +2../0526+".6"/ +/02/+ =isopropylamine salt@ I'#> +/02/0 =sodi!m salt>

GLYPHOSATE RED September 1993

1 - /-*+ #1#00603 2 - /-*+ #1#0060# 3 - /-*+s 00137137, 0013713$, 00137139, 001371#0

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

st!dies with two animal species@ rat and mo!se.

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

is $ 0/ mg?*g?day =HDT>. The

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

offer s!fficient ris* mitigation to wor*ers.

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

GLYPHOSATE RED September 1993

4uideline"5ommodi!y 6171-# 'a(7 8lan! /e!abolism

6171-# 'b(7 %nimal /e!abolism

6171-# 'c( and 'd(7 -esidue %naly!ical /e!hods

1 - /-+ #1#00603 2 - /-+ #1#0060# 3 - /-*+s 00137137, 0013713$, 00137139, 001371#0